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Balanced Crystalloid Solutions for Acute Pancreatitis

Primary Purpose

Acute Pancreatitis

Status
Unknown status
Phase
Phase 4
Locations
Croatia
Study Type
Interventional
Intervention
Balanced crystalloid solution
Normal saline
Sponsored by
University Hospital Rijeka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- patients diagnosed with acute pancreatitis based on the revised Atlanta criteria who present to our hospital within 48 hours of symptoms onset, regardless of etiology, severity of disease, or prior episodes of acute pancreatitis

Exclusion Criteria:

  • chronic pancreatitis
  • liver cirrhosis (Child-Pugh B and C)
  • chronic hearth failure (NYHA>II)
  • acute coronary syndrome
  • cardiovascular intervention within 60 days before randomization
  • chronic obstructive pulmonary disease dependent of home oxygenator or acute exacerbation of chronic obstructive pulmonary disease
  • chronic kidney disease (eGFR <30 ml/min/1.73 m2)
  • concomitant biliary infection (cholecystitis, cholangitis)
  • severe autoimmune disease
  • chronic active infection (TBC, AIDS)
  • metastatic malignant disease
  • primary pancreatic neoplasm
  • patients transferred from other hospitals
  • pregnancy and ongoing breastfeeding
  • not willing to participate

Sites / Locations

  • University Hospital RijekaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Balanced crystalloid solution

Normal saline

Arm Description

Balanced crystalloid solution - Plasmalyte.

0.9% sodium chloride solution.

Outcomes

Primary Outcome Measures

Number of Participants with New Onset Systemic inflammatory response syndrome (SIRS)
Body temperature less than 36 °C (96.8 °F) or greater than 38 °C (100.4 °F); heart rate greater than 90 beats per minute; tachypnea (high respiratory rate), with greater than 20 breaths per minute or, an arterial partial pressure of carbon dioxide less than 4.3 kilopascals (32 mmHg); white blood cell count less than 4000 cells/mm³ (4 x 109 cells/L) or greater than 12,000 cells/mm³ (12 x 109 cells/L) or the presence of greater than 10% immature neutrophils.

Secondary Outcome Measures

Mortality
Number of death cases
Number of participants with organ failure (transitory and persistent)
Organ failure defined according to the modified Marshall criteria
Number of participants with local complications
Local complications including: acute peripancreatic fluid collection acute necrotic collection pseudocyst walled-off necrosis
Number od participants with systemic complications
Worsening of existing concomitant diseases
Number of participants with infected pancreatic necrosis
Defined by positive cultures from fine-needle aspiration of necrotic tissue or by the combination of clinical deterioration with clinical signs of infection and presence of gas within the necrotic tissue on imaging in cases of culture-negative, but highly suspicious cases.
Number of participants needing endoscopic / percutaneous / surgical interventions
In cases when presence of local infection or local complications (i.e. collection compressing surrounding organs and causing symptoms) requires an intervention
Length of hospital stay
Number of days in hospital, from admission to discharge or death.

Full Information

First Posted
December 23, 2020
Last Updated
December 29, 2020
Sponsor
University Hospital Rijeka
Collaborators
University of Rijeka
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1. Study Identification

Unique Protocol Identification Number
NCT04688645
Brief Title
Balanced Crystalloid Solutions for Acute Pancreatitis
Official Title
Treatment With Balanced Crystalloid Solutions in the Early Phase of Acute Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Rijeka
Collaborators
University of Rijeka

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
No

5. Study Description

Brief Summary
Patients diagnosed with acute pancreatitis regardless of etiology, severity of disease, and prior attacks will be randomized in two groups. The intervention group will receive a balanced crystalloid (Plasmalyte) at a rate of 10 ml/kg during the first 60 min and then continued at 3 ml/kg/h for the next 72 hours. The control group will receive normal saline at the same rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
276 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Balanced crystalloid solution
Arm Type
Experimental
Arm Description
Balanced crystalloid solution - Plasmalyte.
Arm Title
Normal saline
Arm Type
Active Comparator
Arm Description
0.9% sodium chloride solution.
Intervention Type
Drug
Intervention Name(s)
Balanced crystalloid solution
Other Intervention Name(s)
Plasmalyte; balanced crystalloids
Intervention Description
Balanced crystalloid solution (Plasmalyte) given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Saline; 0.9% sodium chloride solution
Intervention Description
0.9% sodium chloride solution given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated.
Primary Outcome Measure Information:
Title
Number of Participants with New Onset Systemic inflammatory response syndrome (SIRS)
Description
Body temperature less than 36 °C (96.8 °F) or greater than 38 °C (100.4 °F); heart rate greater than 90 beats per minute; tachypnea (high respiratory rate), with greater than 20 breaths per minute or, an arterial partial pressure of carbon dioxide less than 4.3 kilopascals (32 mmHg); white blood cell count less than 4000 cells/mm³ (4 x 109 cells/L) or greater than 12,000 cells/mm³ (12 x 109 cells/L) or the presence of greater than 10% immature neutrophils.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Mortality
Description
Number of death cases
Time Frame
30 days
Title
Number of participants with organ failure (transitory and persistent)
Description
Organ failure defined according to the modified Marshall criteria
Time Frame
30 days
Title
Number of participants with local complications
Description
Local complications including: acute peripancreatic fluid collection acute necrotic collection pseudocyst walled-off necrosis
Time Frame
30 days
Title
Number od participants with systemic complications
Description
Worsening of existing concomitant diseases
Time Frame
30 days
Title
Number of participants with infected pancreatic necrosis
Description
Defined by positive cultures from fine-needle aspiration of necrotic tissue or by the combination of clinical deterioration with clinical signs of infection and presence of gas within the necrotic tissue on imaging in cases of culture-negative, but highly suspicious cases.
Time Frame
30 days
Title
Number of participants needing endoscopic / percutaneous / surgical interventions
Description
In cases when presence of local infection or local complications (i.e. collection compressing surrounding organs and causing symptoms) requires an intervention
Time Frame
30 days
Title
Length of hospital stay
Description
Number of days in hospital, from admission to discharge or death.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - patients diagnosed with acute pancreatitis based on the revised Atlanta criteria who present to our hospital within 48 hours of symptoms onset, regardless of etiology, severity of disease, or prior episodes of acute pancreatitis Exclusion Criteria: chronic pancreatitis liver cirrhosis (Child-Pugh B and C) chronic hearth failure (NYHA>II) acute coronary syndrome cardiovascular intervention within 60 days before randomization chronic obstructive pulmonary disease dependent of home oxygenator or acute exacerbation of chronic obstructive pulmonary disease chronic kidney disease (eGFR <30 ml/min/1.73 m2) concomitant biliary infection (cholecystitis, cholangitis) severe autoimmune disease chronic active infection (TBC, AIDS) metastatic malignant disease primary pancreatic neoplasm patients transferred from other hospitals pregnancy and ongoing breastfeeding not willing to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Goran Poropat, MD, PhD
Phone
0038551658191
Email
gporopat8@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anja Radovan, MD
Phone
0038551658111
Email
anja.radovan@gmail.com
Facility Information:
Facility Name
University Hospital Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Goran Poropat, MD, PhD
Phone
0038551658379
Email
gporopat8@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Balanced Crystalloid Solutions for Acute Pancreatitis

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