Acetated Ringer's Solution Versus Saline in Patients With Septic Shock

NCT04507672 | Unknown

• 1 other identifier: 2018ZDSYLL105-P01
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Septic Shock Hyperdynamic

Keywords

Crystalloid; Renal failure; Renal dysfunction

Outcome Measures

Primary Outcomes (1)

• Incidence of major adverse renal events in 28 days

  Incidence of major adverse renal events

  28 day

Secondary Outcomes (2)

• Incidence of kidney injury

  28 day

• Serum creatinine（umol/L）

  28 day

Study Arms (2)

saline group

PLACEBO COMPARATOR

Use saline for fluid resuscitation during the first 72 hours after enrollment

Drug: Fluid resuscitation

Acetated Ringer's solution group

EXPERIMENTAL

Use acetated Ringer's solution for fluid resuscitation during the first 72 hours after enrollment

Drug: Fluid resuscitation

Interventions

Fluid resuscitation DRUG

Use the choice of crystalloid for resuscitation during the first 72 hours after enrollment

Acetated Ringer's solution group; saline group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients presenting to the ICU diagnosed as septic shock within 24 hours.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southeast University, China: lead

Related Publications (7)

• 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.

  PMID: 24638143 RESULT

• 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.

  PMID: 30075798 RESULT

• 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.

  PMID: 21705897 RESULT

• 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.

  PMID: 27716310 RESULT

• 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.

  PMID: 24674927 RESULT

• 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.

  PMID: 23073953 RESULT

• 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.

  PMID: 29485925 RESULT

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zhongda Hospital,Southeast University, China

Model Details: Cluster-randomized, multiple-center trial

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: August 11, 2020
• Study Start: September 1, 2020
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 11, 2020

Record last verified: 2020-08