Controlled Fluid Resuscitation in Sepsis
Primary Purpose
Sepsis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early Goal Directed Therapy
Ruijin Strategy
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis focused on measuring resuscitation, fluid therapy
Eligibility Criteria
Inclusion Criteria:
- 1.sepsis patients in accordance with the Sepsis 3.0 definition(SOFA increase ≥2 compared to the baseline,due to infection )
- 2.the first blood lactate in our hospital is ≥ 4mmol/L or MAP<90mmHg after 20ml/kg fluid bolus
- 3.the shock is diagnosed within 24hrs after onset
Exclusion Criteria:
- - 1.<18 years old
- 2.Pregnancy
- 3 with co-morbidity such as AE-COPD, stroke, seizure, lung edema, acute coronary syndrome
- 4 with contra-indication of CVC(central venous catheter) placement
- 5 trauma or major burn
- 6 poisoning
- 7 any cancer receiving chemotherapy
- 8.immunosuppression (for organ transplantation or disease of immune system)
- 9.acute pancreatitis
- 10.relapse sepsis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
EGDT Group
Ruijin Group
Arm Description
Early Goal Directed Therapy :30ml/kg in the first bolus to have a CVP(central venous pressure) 8-12 mmHg and MAP(mean artery pressure ) 65-85 mm Hg,and urine output ≥0.5 ml/kg/h, ScvO2 ≤70%;If not, use noradrenaline,red blood cell transfusion if necessary.
Ruijin Strategy therapy:10~5ml/kg/h,crystalloid vs colloid 2:1 resuscitation;using noradrenaline at the same time;red blood cell transfusion if necessary. target: fulfillment of two or more of four criteria:1. HR(heart rate) <120 beats/min, 2.MAP 65-85 mm Hg, 3. urine output ≥1 ml/kg /h 4. HCT(hematocrit) 25%~35%.
Outcomes
Primary Outcome Measures
Mortality
Mortality
Secondary Outcome Measures
Mortality
Mortality
Full Information
NCT ID
NCT03214913
First Posted
July 7, 2017
Last Updated
July 8, 2017
Sponsor
Ruijin Hospital
Collaborators
RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03214913
Brief Title
Controlled Fluid Resuscitation in Sepsis
Official Title
Controlled Fluid Resuscitation Strategy in Sepsis Patient
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate two different strategy of fluid resuscitation in sepsis patients
Detailed Description
Early goal-directed fluid therapy (EGDT) had been regarded as an important fluid therapy strategy in early sepsis or septic shock patients. In recent years, several randomized control studies showed the EGDT therapy cannot make a better outcome in sepsis patients compared to the standard therapy. A strategy of controlled fluid resuscitation had showed good outcome in critical illness such as severe acute pancreatitis, major trauma. But many aspects of the so-called controlled fluid resuscitation remained controversial. In a previous study on severe acute pancreatitis, we described a bundle of controlled fluid resuscitation which had showed an ideal result with higher survival rate. So, we are going to use the bundle on sepsis patients, and to see if it can bring a better out come in sepsis patients compared to the EGDT strategy. This study aims to determine a better strategy of fluid resuscitation in sepsis patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
resuscitation, fluid therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
550 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EGDT Group
Arm Type
Other
Arm Description
Early Goal Directed Therapy :30ml/kg in the first bolus to have a CVP(central venous pressure) 8-12 mmHg and MAP(mean artery pressure ) 65-85 mm Hg,and urine output ≥0.5 ml/kg/h, ScvO2 ≤70%;If not, use noradrenaline,red blood cell transfusion if necessary.
Arm Title
Ruijin Group
Arm Type
Other
Arm Description
Ruijin Strategy therapy:10~5ml/kg/h,crystalloid vs colloid 2:1 resuscitation;using noradrenaline at the same time;red blood cell transfusion if necessary.
target: fulfillment of two or more of four criteria:1. HR(heart rate) <120 beats/min, 2.MAP 65-85 mm Hg, 3. urine output ≥1 ml/kg /h 4. HCT(hematocrit) 25%~35%.
Intervention Type
Other
Intervention Name(s)
Early Goal Directed Therapy
Other Intervention Name(s)
EGDT therapy
Intervention Description
EGDT therapy :30ml/kg in the first bolus to have a CVP 8-12 mmHg and MAP 65-85 mm Hg,and urine output ≥0.5 ml/kg/h, ScvO2 ≤70%;If not, use noradrenine,red blood cell transfusion if necessary.
Intervention Type
Other
Intervention Name(s)
Ruijin Strategy
Other Intervention Name(s)
controlled fluid therapy
Intervention Description
Ruijin Strategy:10~5ml/kg/h,crystalloid vs colloid 2:1 resuscitation;using noradrenaline at the same time;red blood cell transfusion if necessary.
target: fulfillment of two or more of four criteria:1. HR <120 beats/min, 2.MAP 65-85 mm Hg, 3. urine output ≥1 ml/kg /h 4. HCT 25%~35%.
Primary Outcome Measure Information:
Title
Mortality
Description
Mortality
Time Frame
the 28th day from enrolled
Secondary Outcome Measure Information:
Title
Mortality
Description
Mortality
Time Frame
the 60th day from enrolled
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.sepsis patients in accordance with the Sepsis 3.0 definition(SOFA increase ≥2 compared to the baseline,due to infection )
2.the first blood lactate in our hospital is ≥ 4mmol/L or MAP<90mmHg after 20ml/kg fluid bolus
3.the shock is diagnosed within 24hrs after onset
Exclusion Criteria:
- 1.<18 years old
2.Pregnancy
3 with co-morbidity such as AE-COPD, stroke, seizure, lung edema, acute coronary syndrome
4 with contra-indication of CVC(central venous catheter) placement
5 trauma or major burn
6 poisoning
7 any cancer receiving chemotherapy
8.immunosuppression (for organ transplantation or disease of immune system)
9.acute pancreatitis
10.relapse sepsis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang En Mao, Doctor
Phone
+86 18917762931
Email
maoeq@yeah.net
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Er Chen, Doctor
Phone
+86 18917762828
Email
chenerzhen@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen Er Chen
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19187641
Citation
Mao EQ, Tang YQ, Fei J, Qin S, Wu J, Li L, Min D, Zhang SD. Fluid therapy for severe acute pancreatitis in acute response stage. Chin Med J (Engl). 2009 Jan 20;122(2):169-73.
Results Reference
background
PubMed Identifier
25272316
Citation
ARISE Investigators; ANZICS Clinical Trials Group; Peake SL, Delaney A, Bailey M, Bellomo R, Cameron PA, Cooper DJ, Higgins AM, Holdgate A, Howe BD, Webb SA, Williams P. Goal-directed resuscitation for patients with early septic shock. N Engl J Med. 2014 Oct 16;371(16):1496-506. doi: 10.1056/NEJMoa1404380. Epub 2014 Oct 1.
Results Reference
background
PubMed Identifier
16714767
Citation
National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.
Results Reference
background
PubMed Identifier
26903338
Citation
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
Results Reference
background
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Controlled Fluid Resuscitation in Sepsis
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