Acetated Ringer's Solution Versus Saline in Patients With Septic Shock
Primary Purpose
Septic Shock Hyperdynamic
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluid resuscitation
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock Hyperdynamic focused on measuring Crystalloid, Renal failure, Renal dysfunction
Eligibility Criteria
Inclusion Criteria:
Adult patients presenting to the ICU diagnosed as septic shock within 24 hours.
Exclusion Criteria:
- Pregnancy;
- Likely requirement for immediate hemodialysis or renal replacement therapy;
- Patients have already received fluids for more than 4 liters;
- Patient in extremis or death deemed imminent and inevitable.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
saline group
Acetated Ringer's solution group
Arm Description
Use saline for fluid resuscitation during the first 72 hours after enrollment
Use acetated Ringer's solution for fluid resuscitation during the first 72 hours after enrollment
Outcomes
Primary Outcome Measures
Incidence of major adverse renal events in 28 days
Incidence of major adverse renal events
Secondary Outcome Measures
Incidence of kidney injury
Incidence of kidney injury
Serum creatinine(umol/L)
serum creatinine(umol/L)
Full Information
NCT ID
NCT04507672
First Posted
July 2, 2020
Last Updated
August 9, 2020
Sponsor
Southeast University, China
1. Study Identification
Unique Protocol Identification Number
NCT04507672
Brief Title
Acetated Ringer's Solution Versus Saline in Patients With Septic Shock
Official Title
Acetated Ringer's Solution Versus Saline in Patients With Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
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
The primary aim of this trial is to compare the effect of acetated ringer's solution with that of saline for therapy on the incidence and development of major adverse renal events among septic shock patients. The investigators hypothesize that use of acetated ringer's solution for resuscitation among septic shock patients will reduce the incidence of major adverse kidney events.
Detailed Description
Normal saline and Ringer's solutions are the preferred crystalloid fluids administered in early septic shock. However, evidence have associated saline with hyperchloremia and secondary metabolic acidosis, and renal vasoconstriction, increased incidence of acute kidney injury (AKI) and mortality. The primary aim of this trial is to compare the effect of acetated ringer's solution with that of saline for therapy on the incidence and development of major adverse renal events among septic shock patients. The investigators hypothesize that use of acetated ringer's solution for resuscitation among septic shock patients will reduce the incidence of major adverse kidney events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock Hyperdynamic
Keywords
Crystalloid, Renal failure, Renal dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Cluster-randomized, multiple-center trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
saline group
Arm Type
Placebo Comparator
Arm Description
Use saline for fluid resuscitation during the first 72 hours after enrollment
Arm Title
Acetated Ringer's solution group
Arm Type
Experimental
Arm Description
Use acetated Ringer's solution for fluid resuscitation during the first 72 hours after enrollment
Intervention Type
Drug
Intervention Name(s)
Fluid resuscitation
Intervention Description
Use the choice of crystalloid for resuscitation during the first 72 hours after enrollment
Primary Outcome Measure Information:
Title
Incidence of major adverse renal events in 28 days
Description
Incidence of major adverse renal events
Time Frame
28 day
Secondary Outcome Measure Information:
Title
Incidence of kidney injury
Description
Incidence of kidney injury
Time Frame
28 day
Title
Serum creatinine(umol/L)
Description
serum creatinine(umol/L)
Time Frame
28 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients presenting to the ICU diagnosed as septic shock within 24 hours.
Exclusion Criteria:
Pregnancy;
Likely requirement for immediate hemodialysis or renal replacement therapy;
Patients have already received fluids for more than 4 liters;
Patient in extremis or death deemed imminent and inevitable.
12. IPD Sharing Statement
Citations:
PubMed Identifier
24638143
Citation
Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014 Apr 2;311(13):1308-16. doi: 10.1001/jama.2014.2637.
Results Reference
result
PubMed Identifier
30075798
Citation
Peters E, Antonelli M, Wittebole X, Nanchal R, Francois B, Sakr Y, Vincent JL, Pickkers P. A worldwide multicentre evaluation of the influence of deterioration or improvement of acute kidney injury on clinical outcome in critically ill patients with and without sepsis at ICU admission: results from The Intensive Care Over Nations audit. Crit Care. 2018 Aug 3;22(1):188. doi: 10.1186/s13054-018-2112-z.
Results Reference
result
PubMed Identifier
21705897
Citation
Yunos NM, Kim IB, Bellomo R, Bailey M, Ho L, Story D, Gutteridge GA, Hart GK. The biochemical effects of restricting chloride-rich fluids in intensive care. Crit Care Med. 2011 Nov;39(11):2419-24. doi: 10.1097/CCM.0b013e31822571e5.
Results Reference
result
PubMed Identifier
27716310
Citation
Suetrong B, Pisitsak C, Boyd JH, Russell JA, Walley KR. Hyperchloremia and moderate increase in serum chloride are associated with acute kidney injury in severe sepsis and septic shock patients. Crit Care. 2016 Oct 6;20(1):315. doi: 10.1186/s13054-016-1499-7.
Results Reference
result
PubMed Identifier
24674927
Citation
Raghunathan K, Shaw A, Nathanson B, Sturmer T, Brookhart A, Stefan MS, Setoguchi S, Beadles C, Lindenauer PK. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis*. Crit Care Med. 2014 Jul;42(7):1585-91. doi: 10.1097/CCM.0000000000000305.
Results Reference
result
PubMed Identifier
23073953
Citation
Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.
Results Reference
result
PubMed Identifier
29485925
Citation
Semler MW, Self WH, Wanderer JP, Ehrenfeld JM, Wang L, Byrne DW, Stollings JL, Kumar AB, Hughes CG, Hernandez A, Guillamondegui OD, May AK, Weavind L, Casey JD, Siew ED, Shaw AD, Bernard GR, Rice TW; SMART Investigators and the Pragmatic Critical Care Research Group. Balanced Crystalloids versus Saline in Critically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):829-839. doi: 10.1056/NEJMoa1711584. Epub 2018 Feb 27.
Results Reference
result
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Acetated Ringer's Solution Versus Saline in Patients With Septic Shock
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