Back to resultsNormal Saline Versus Lactated Ringer's Solution for Acute Pancreatitis Resuscitation (WATERLAND)
Primary Purpose
Acute Pancreatitis
Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Lactated Ringer Solution
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pancreatitis focused on measuring Normal saline, Lactated Ringer solution, Acute pancreatitis, Fluid Therapy, Fluid resuscitation
Eligibility Criteria
Inclusion Criteria: Patient is 18 years or older Diagnosis of acute pancreatitis according to the revision of the Atlanta classification (Banks et al, Gut 2013), which requires at least two of the following three criteria: A) typical abdominal pain, B) increase in serum amylase or lipase levels higher than three times the upper limit of normality, and C) signs of acute pancreatitis in imaging Signature of informed consent Exclusion Criteria: New York Heart Association class II heart failure (slight limitation of physical activity; fatigue, palpitations, or dyspnea with ordinal physical activity) or worse, or ejection fraction <50% in the last echocardiography Decompensated cirrhosis (Child's class B or C) Hyper or hyponatremia (<135 or >145 mEq/L) Hyperkalemia (>5 mEq/L) Hypercalcemia (albumin or protein-corrected calcium >10.5 mg/dL or 2.62 mmol/L) Criteria for moderately severe or severe acute pancreatitis (revision of the Atlanta classification, Banks et al, Gut 2013) at recruitment: any of the following: A) presence of creatinine ≥1.9 mg/dL or ≥170 mmol/l, B) PaO2/FiO2≤300, C) systolic blood pressure <90 mmHg despite initial fluid resuscitation, D) presence of local complications (acute peripancreatic fluid collections, acute necrotic collection, pseudocyst, walled-off necrosis, gastric outlet dysfunction, splenic or portal vein thrombosis, or colonic necrosis), E) exacerbation of previous comorbidity such as coronary artery disease or chronic lung disease, precipitated by the acute pancreatitis Signs of volume overload or heart failure at recruitment (peripheral edema, pulmonary rales, or increased jugular ingurgitation at 45º) Time from pain onset to arrival to emergency room >12 h Time from confirmation of pancreatitis to randomization >8 h Chronic pancreatitis defined by a Wirsung duct ≥4mm and/or pancreatic calcifications More than 1 previous episode of acute pancreatitis (only 2 episodes of acute pancreatitis are allowed, one of them the present episode)
Sites / Locations
- Dr. Balmis General University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lactated Ringer solution (LR)
Normal saline (NS)
Arm Description
LR: Lactated Ringer solution. Patients in the LR treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours.
NS: Normal Saline. Patients in the NS treatment arm will receive fluid therapy based on normal saline for a minimum of 48 hours.
Outcomes
Primary Outcome Measures
Number of Participants with moderately severe or severe acute pancreatitis
Presence of local complications, exacerbation of previous comorbidity or organ failure, according to the definitions of these complications provided by the revised Atlanta Classification (https://doi.org/10.1136/gutjnl-2012-302779)
Secondary Outcome Measures
Number of participants with local complications
Presence of acute peripancreatic fluid collections, acute necrotic collection, pseudocyst, walled-off necrosis, gastric outlet dysfunction, splenic or portal vein thrombosis, and colonic necrosis according to the revised Atlanta Classification (https://doi.org/10.1136/gutjnl-2012-302779).
Number of participants with necrotizing pancreatitis
Presence of acute necrotic collections according to the revised Atlanta Classification (https://doi.org/10.1136/gutjnl-2012-302779).
Number of participants with systemic inflammatory response syndrome
At least 2 criteria: A) pulse >90 beats/min, B) respirations >20/min or arterial blood PaCO2 <32 mm Hg, C) temperature <36°C or >38°C, D) white blood cell count <4,000 cells/mm3 or >12,000 cells/mm3 or >10% bands
Number of systemic inflammatory response syndrome criteria
The criteria are: A) pulse >90 beats/min, B) respirations >20/min or arterial blood PaCO2 <32 mm Hg, C) temperature <36°C or >38°C, D) white blood cell count <4,000 cells/mm3 or >12,000 cells/mm3 or >10% bands
PAN-PROMISE symptom scale
PAN-PROMISE scale: a 7-symptom scale patient-reported outcome (range, 0 to 10 for each symptom; overall range, 0 to 70, with higher scores indicating higher symptom intensity). Details: https://doi.org/10.1136/gutjnl-2020-320729
Time to oral refeeding
Days from baseline to oral refeeding
Number of participants with invasive treatment
Any of the following: thoracocentesis due to pancreatitis-induced pleural effusion, percutaneous and/or endoscopic drainage of pancreatic or peripancreatic fluid collections or necrosis, endoscopic or surgical necrosectomy, endoscopic retrograde cholangiopancreatography due to A) ruptured common bile duct, B) jaundice caused by compression of the common bile duct, C) main pancreatic duct leakage
Number of participants with nutritional support
Use of enteral (nasogastric or nasojejunal) or parenteral feeding
Number of participants with intensive care unit admission
Admission in the intensive care unit
Number of participants with exacerbation of coexisting condition
Exacerbation of pre-existing co-morbidity. The definition provided by the Revised Atlanta Classification is " Exacerbation of pre-existing co-morbidity, such as coronary artery disease or chronic lung disease, precipitated by the acute pancreatitis is defined as a systemic complication. In this document, we distinguish between persistent organ failure (the defining feature of severe acute pancreatitis) and other systemic complications, which are an exacerbation of pre-existing co-morbid disease." (revised Atlanta classification: https://doi.org/10.1136/gutjnl-2012-302779) For the WATERLAND trial we define exacerbation of pre-existing co-morbidity as
Number of participants with any organ failure
Definition according to the revised Atlanta classification (https://doi.org/10.1136/gutjnl-2012-302779): organ failure is defined by the presence of any of the following criteria: A) kidney failure as a creatinine ≥1.9 mg/dL or >170 micromol/L, B) cardiovascular failure as a systolic blood pressure <90 mmHg despite fluid resuscitation, and C) respiratory failure as a PaO2/FIO2≤300
Number of participants with persistent organ failure
Organ failure lasting more than 48h (revised Atlanta classification: https://doi.org/10.1136/gutjnl-2012-302779)
Number of participants with shock
Systolic blood pressure <90 mmHg despite fluid resuscitation (revised Atlanta classification: https://doi.org/10.1136/gutjnl-2012-302779)
Number of participants with respiratory failure
PaO2/FIO2≤300 (revised Atlanta classification: https://doi.org/10.1136/gutjnl-2012-302779)
Number of participants with kidney failure
Creatinine ≥1.9 mg/dL or >170 micromol/L (revised Atlanta classification: https://doi.org/10.1136/gutjnl-2012-302779)
Mortality (number of participants)
Death
Hospital stay
Days from recruitment to discharge from index admission
C-reactive protein
C-reactive protein blood levels
Number of participants with hypovolemia
WATERFALL trial criteria for hypovolemia (see https://www.nejm.org/doi/10.1056/NEJMoa2202884)
Number of participants with fluid overload
WATERFALL trial criteria for fluid overload (see https://www.nejm.org/doi/10.1056/NEJMoa2202884)
Number of participants with acute kidney injury
KDIGO criteria: increase in serum creatinine of ≥0.3 mg/dL within 48 hr or ≥50% within 7 days or urine output of <0.5 mL/kg/hr for >6 hr (https://doi.org/10.1159/000339789)
Number of participants with hyperkalemia
Venous potassium>5mEq/L
Number of participants with hypercalcemia
Venous calcium corrected by proteins>10.5mg/dL or 2.62 mmol/L
Number of participants with hyperchloremia
Venous chloride>106mEq/L
Number of participants with acidosis
Venous blood pH <7.35
Number of participants with composite safety outcome (primary safety outcome)
Fluid overload or acute kidney injury or hyperkalemia or hypercalcemia or hyperchloremia or acidosis
Full Information
NCT ID
NCT05781243
First Posted
February 25, 2023
Last Updated
September 21, 2023
Sponsor
Enrique de-Madaria
Collaborators
Instituto de Salud Carlos III, Universidad Miguel Hernandez de Elche, Hospital del Mar, Hospital Clinico Universitario de Santiago, Hospital Clínico Universitario de Valencia, Hospital Costa del Sol, Corporacion Parc Tauli, Hospital Clínico Universitario Lozano Blesa, Hospital General Universitario Gregorio Marañon, Hospital Universitario La Fe, Hospital Miguel Servet, Hospital Universitario Ramon y Cajal, Hospital Universitario Insular Gran Canaria, University Hospital Virgen de las Nieves, Hospital Universitario de Burgos, Hospital Universitario Lucus Augusti, Hospital Universitario Marqués de Valdecilla, Hospital Universitario Puerta del Mar, Instituto de Investigación Sanitaria Hospital Universitario de la Princesa, Dr. Negrin University Hospital, Hospital Regional de Alta Especialidad del Bajio, Asian Institute Of Medical Sciences, Hospital Dr. Jaime Mendoza Sucre Bolivia, Hayatabad Medical Complex, University Hospital Olomouc, SIDS Hospital & Research Centre Gujarat India, Sanatorio Allende, University Hospital Bratislava, University Hospital "Sestre Milosrdnice", Attikon Hospital, Nuevo Hospital Iturraspe Santa Fe Argentina, Hospital Nacional Rosales, Zagazig University
1. Study Identification
Unique Protocol Identification Number
NCT05781243
Brief Title
Normal Saline Versus Lactated Ringer's Solution for Acute Pancreatitis Resuscitation
Acronym
WATERLAND
Official Title
Normal Saline Versus Lactated Ringer's Solution for Acute Pancreatitis Resuscitation, an Open-label Multicenter Randomized Controlled Trial: the WATERLAND Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2023 (Actual)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Enrique de-Madaria
Collaborators
Instituto de Salud Carlos III, Universidad Miguel Hernandez de Elche, Hospital del Mar, Hospital Clinico Universitario de Santiago, Hospital Clínico Universitario de Valencia, Hospital Costa del Sol, Corporacion Parc Tauli, Hospital Clínico Universitario Lozano Blesa, Hospital General Universitario Gregorio Marañon, Hospital Universitario La Fe, Hospital Miguel Servet, Hospital Universitario Ramon y Cajal, Hospital Universitario Insular Gran Canaria, University Hospital Virgen de las Nieves, Hospital Universitario de Burgos, Hospital Universitario Lucus Augusti, Hospital Universitario Marqués de Valdecilla, Hospital Universitario Puerta del Mar, Instituto de Investigación Sanitaria Hospital Universitario de la Princesa, Dr. Negrin University Hospital, Hospital Regional de Alta Especialidad del Bajio, Asian Institute Of Medical Sciences, Hospital Dr. Jaime Mendoza Sucre Bolivia, Hayatabad Medical Complex, University Hospital Olomouc, SIDS Hospital & Research Centre Gujarat India, Sanatorio Allende, University Hospital Bratislava, University Hospital "Sestre Milosrdnice", Attikon Hospital, Nuevo Hospital Iturraspe Santa Fe Argentina, Hospital Nacional Rosales, Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background: Acute pancreatitis (AP) is an acute inflammatory disease of variable severity. Mild cases have an uncomplicated clinical course, but local and systemic complications occur in one-third of patients and are associated with a longer hospital stay, increased morbidity, increased hospital costs, and increased risk of death. Some evidence suggests that fluid resuscitation with lactated Ringer's solution (LR) may have an anti-inflammatory effect on AP when compared to normal saline (NS), and may be associated with a decrease in severity, but randomized controlled trials showed conflicting results. The WATERLAND trial has been designed to investigate the efficacy and safety of fluid resuscitation using LR as compared with NS in patients with AP.
Methods: The WATERLAND trial is an international multicenter, open-label, parallel-group, randomized, controlled, superiority trial. Patients will be randomly assigned in a 1:1 ratio to receive LR versus NS-based moderate fluid resuscitation. The primary outcome will be moderately severe to severe AP, according to the revision of the Atlanta classification. The primary safety outcome will be a composite variable involving any of the following: fluid overload, acute kidney injury, hyperkalemia, hypercalcemia, or acidosis. A total sample of 720 patients, 360 in the LR group and 360 in the NS group will achieve 90% power to detect a difference between the group proportions of 10%, assuming that the frequency of moderately severe to severe AP in LR group will be 17%. The frequency in the NS group is assumed to be 27% under the null hypothesis and 17% under the alternative hypothesis. The test statistic used is the two-sided Z test with pooled variance set at a 0.05 significance level.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
Normal saline, Lactated Ringer solution, Acute pancreatitis, Fluid Therapy, Fluid resuscitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
720 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lactated Ringer solution (LR)
Arm Type
Experimental
Arm Description
LR: Lactated Ringer solution. Patients in the LR treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours.
Arm Title
Normal saline (NS)
Arm Type
Active Comparator
Arm Description
NS: Normal Saline. Patients in the NS treatment arm will receive fluid therapy based on normal saline for a minimum of 48 hours.
Intervention Type
Drug
Intervention Name(s)
Lactated Ringer Solution
Intervention Description
Patients in the LR (Lactated Ringer solution) treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Patients in the NS (Normal Saline) treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours.
Primary Outcome Measure Information:
Title
Number of Participants with moderately severe or severe acute pancreatitis
Description
Presence of local complications, exacerbation of previous comorbidity or organ failure, according to the definitions of these complications provided by the revised Atlanta Classification (https://doi.org/10.1136/gutjnl-2012-302779)
Time Frame
From date of randomization until 30 days after randomization
Secondary Outcome Measure Information:
Title
Number of participants with local complications
Description
Presence of acute peripancreatic fluid collections, acute necrotic collection, pseudocyst, walled-off necrosis, gastric outlet dysfunction, splenic or portal vein thrombosis, and colonic necrosis according to the revised Atlanta Classification (https://doi.org/10.1136/gutjnl-2012-302779).
Time Frame
From date of randomization until 30 days after randomization
Title
Number of participants with necrotizing pancreatitis
Description
Presence of acute necrotic collections according to the revised Atlanta Classification (https://doi.org/10.1136/gutjnl-2012-302779).
Time Frame
From date of randomization until 30 days after randomization
Title
Number of participants with systemic inflammatory response syndrome
Description
At least 2 criteria: A) pulse >90 beats/min, B) respirations >20/min or arterial blood PaCO2 <32 mm Hg, C) temperature <36°C or >38°C, D) white blood cell count <4,000 cells/mm3 or >12,000 cells/mm3 or >10% bands
Time Frame
At 24 and 48 hours
Title
Number of systemic inflammatory response syndrome criteria
Description
The criteria are: A) pulse >90 beats/min, B) respirations >20/min or arterial blood PaCO2 <32 mm Hg, C) temperature <36°C or >38°C, D) white blood cell count <4,000 cells/mm3 or >12,000 cells/mm3 or >10% bands
Time Frame
At 24 and 48 hours
Title
PAN-PROMISE symptom scale
Description
PAN-PROMISE scale: a 7-symptom scale patient-reported outcome (range, 0 to 10 for each symptom; overall range, 0 to 70, with higher scores indicating higher symptom intensity). Details: https://doi.org/10.1136/gutjnl-2020-320729
Time Frame
At 24 and 48 hours (change from baseline)
Title
Time to oral refeeding
Description
Days from baseline to oral refeeding
Time Frame
From date of randomization until 30 days after randomization
Title
Number of participants with invasive treatment
Description
Any of the following: thoracocentesis due to pancreatitis-induced pleural effusion, percutaneous and/or endoscopic drainage of pancreatic or peripancreatic fluid collections or necrosis, endoscopic or surgical necrosectomy, endoscopic retrograde cholangiopancreatography due to A) ruptured common bile duct, B) jaundice caused by compression of the common bile duct, C) main pancreatic duct leakage
Time Frame
From date of randomization until 30 days after randomization
Title
Number of participants with nutritional support
Description
Use of enteral (nasogastric or nasojejunal) or parenteral feeding
Time Frame
From date of randomization until 30 days after randomization
Title
Number of participants with intensive care unit admission
Description
Admission in the intensive care unit
Time Frame
From date of randomization until 30 days after randomization
Title
Number of participants with exacerbation of coexisting condition
Description
Exacerbation of pre-existing co-morbidity. The definition provided by the Revised Atlanta Classification is " Exacerbation of pre-existing co-morbidity, such as coronary artery disease or chronic lung disease, precipitated by the acute pancreatitis is defined as a systemic complication. In this document, we distinguish between persistent organ failure (the defining feature of severe acute pancreatitis) and other systemic complications, which are an exacerbation of pre-existing co-morbid disease." (revised Atlanta classification: https://doi.org/10.1136/gutjnl-2012-302779) For the WATERLAND trial we define exacerbation of pre-existing co-morbidity as
Time Frame
From date of randomization until 30 days after randomization
Title
Number of participants with any organ failure
Description
Definition according to the revised Atlanta classification (https://doi.org/10.1136/gutjnl-2012-302779): organ failure is defined by the presence of any of the following criteria: A) kidney failure as a creatinine ≥1.9 mg/dL or >170 micromol/L, B) cardiovascular failure as a systolic blood pressure <90 mmHg despite fluid resuscitation, and C) respiratory failure as a PaO2/FIO2≤300
Time Frame
From date of randomization until 30 days after randomization
Title
Number of participants with persistent organ failure
Description
Organ failure lasting more than 48h (revised Atlanta classification: https://doi.org/10.1136/gutjnl-2012-302779)
Time Frame
From date of randomization until 30 days after randomization
Title
Number of participants with shock
Description
Systolic blood pressure <90 mmHg despite fluid resuscitation (revised Atlanta classification: https://doi.org/10.1136/gutjnl-2012-302779)
Time Frame
From date of randomization until 30 days after randomization
Title
Number of participants with respiratory failure
Description
PaO2/FIO2≤300 (revised Atlanta classification: https://doi.org/10.1136/gutjnl-2012-302779)
Time Frame
From date of randomization until 30 days after randomization
Title
Number of participants with kidney failure
Description
Creatinine ≥1.9 mg/dL or >170 micromol/L (revised Atlanta classification: https://doi.org/10.1136/gutjnl-2012-302779)
Time Frame
From date of randomization until 30 days after randomization
Title
Mortality (number of participants)
Description
Death
Time Frame
From date of randomization until 30 days after randomization
Title
Hospital stay
Description
Days from recruitment to discharge from index admission
Time Frame
From date of randomization until 30 days after randomization
Title
C-reactive protein
Description
C-reactive protein blood levels
Time Frame
At 48 hours from randomization
Title
Number of participants with hypovolemia
Description
WATERFALL trial criteria for hypovolemia (see https://www.nejm.org/doi/10.1056/NEJMoa2202884)
Time Frame
At 24 and 48 hours from randomization
Title
Number of participants with fluid overload
Description
WATERFALL trial criteria for fluid overload (see https://www.nejm.org/doi/10.1056/NEJMoa2202884)
Time Frame
At 24 and 48 hours from randomization
Title
Number of participants with acute kidney injury
Description
KDIGO criteria: increase in serum creatinine of ≥0.3 mg/dL within 48 hr or ≥50% within 7 days or urine output of <0.5 mL/kg/hr for >6 hr (https://doi.org/10.1159/000339789)
Time Frame
At 24 and 48 hours from randomization
Title
Number of participants with hyperkalemia
Description
Venous potassium>5mEq/L
Time Frame
At 24 and 48 hours from randomization
Title
Number of participants with hypercalcemia
Description
Venous calcium corrected by proteins>10.5mg/dL or 2.62 mmol/L
Time Frame
At 24 and 48 hours from randomization
Title
Number of participants with hyperchloremia
Description
Venous chloride>106mEq/L
Time Frame
At 24 and 48 hours from randomization
Title
Number of participants with acidosis
Description
Venous blood pH <7.35
Time Frame
At 24 and 48 hours from randomization
Title
Number of participants with composite safety outcome (primary safety outcome)
Description
Fluid overload or acute kidney injury or hyperkalemia or hypercalcemia or hyperchloremia or acidosis
Time Frame
At 24 and 48 hours from randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is 18 years or older
Diagnosis of acute pancreatitis according to the revision of the Atlanta classification (Banks et al, Gut 2013), which requires at least two of the following three criteria: A) typical abdominal pain, B) increase in serum amylase or lipase levels higher than three times the upper limit of normality, and C) signs of acute pancreatitis in imaging
Signature of informed consent
Exclusion Criteria:
New York Heart Association class II heart failure (slight limitation of physical activity; fatigue, palpitations, or dyspnea with ordinal physical activity) or worse, or ejection fraction <50% in the last echocardiography
Decompensated cirrhosis (Child's class B or C)
Hyper or hyponatremia (<135 or >145 mEq/L)
Hyperkalemia (>5 mEq/L)
Hypercalcemia (albumin or protein-corrected calcium >10.5 mg/dL or 2.62 mmol/L)
Criteria for moderately severe or severe acute pancreatitis (revision of the Atlanta classification, Banks et al, Gut 2013) at recruitment: any of the following: A) presence of creatinine ≥1.9 mg/dL or ≥170 mmol/l, B) PaO2/FiO2≤300, C) systolic blood pressure <90 mmHg despite initial fluid resuscitation, D) presence of local complications (acute peripancreatic fluid collections, acute necrotic collection, pseudocyst, walled-off necrosis, gastric outlet dysfunction, splenic or portal vein thrombosis, or colonic necrosis), E) exacerbation of previous comorbidity such as coronary artery disease or chronic lung disease, precipitated by the acute pancreatitis
Signs of volume overload or heart failure at recruitment (peripheral edema, pulmonary rales, or increased jugular ingurgitation at 45º)
Time from pain onset to arrival to emergency room >12 h
Time from confirmation of pancreatitis to randomization >8 h
Chronic pancreatitis defined by a Wirsung duct ≥4mm and/or pancreatic calcifications
More than 1 previous episode of acute pancreatitis (only 2 episodes of acute pancreatitis are allowed, one of them the present episode)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia Vaillo-Rocamora, BPHARM
Phone
0034 965913975
Email
vailloalicia@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique de-Madaria, MD PhD
Organizational Affiliation
Dr. Balmis General University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Balmis General University Hospital
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Vaillo-Rocamora, BPHARM
Phone
0034 965913975
Email
vailloalicia@gmail.com
First Name & Middle Initial & Last Name & Degree
Enrique de Madaria, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Members of the ERICA consortium that recruited patients in the WATERLAND trial may claim access to the final dataset to perform post-hoc studies; these proposals will be studied by the steering committee.
IPD Sharing Time Frame
Data will be available upon publication of the main study.
IPD Sharing Access Criteria
Have enrolled patients in the WATERLAND study.
The Steering Committee will evaluate the project and decide whether it is of sufficient scientific quality.
Citations:
PubMed Identifier
23100216
Citation
Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
Results Reference
background
PubMed Identifier
36103415
Citation
de-Madaria E, Buxbaum JL, Maisonneuve P, Garcia Garcia de Paredes A, Zapater P, Guilabert L, Vaillo-Rocamora A, Rodriguez-Gandia MA, Donate-Ortega J, Lozada-Hernandez EE, Collazo Moreno AJR, Lira-Aguilar A, Llovet LP, Mehta R, Tandel R, Navarro P, Sanchez-Pardo AM, Sanchez-Marin C, Cobreros M, Fernandez-Cabrera I, Casals-Seoane F, Casas Deza D, Lauret-Brana E, Marti-Marques E, Camacho-Montano LM, Ubieto V, Ganuza M, Bolado F; ERICA Consortium. Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis. N Engl J Med. 2022 Sep 15;387(11):989-1000. doi: 10.1056/NEJMoa2202884.
Results Reference
background
PubMed Identifier
32245906
Citation
de-Madaria E, Sanchez-Marin C, Carrillo I, Vege SS, Chooklin S, Bilyak A, Mejuto R, Mauriz V, Hegyi P, Marta K, Kamal A, Lauret-Brana E, Barbu ST, Nunes V, Ruiz-Rebollo ML, Garcia-Rayado G, Lozada-Hernandez EE, Pereira J, Negoi I, Espina S, Hollenbach M, Litvin A, Bolado-Concejo F, Vargas RD, Pascual-Moreno I, Singh VK, Mira JJ. Design and validation of a patient-reported outcome measure scale in acute pancreatitis: the PAN-PROMISE study. Gut. 2021 Jan;70(1):139-147. doi: 10.1136/gutjnl-2020-320729. Epub 2020 Apr 3.
Results Reference
background
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Normal Saline Versus Lactated Ringer's Solution for Acute Pancreatitis Resuscitation
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