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

Septic Shock Hyperdynamic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04507672
• Other study ID #: 2018ZDSYLL105-P01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2020
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnancy;

2. Likely requirement for immediate hemodialysis or renal replacement therapy;

3. Patients have already received fluids for more than 4 liters;

4. Patient in extremis or death deemed imminent and inevitable.

Related Conditions & MeSH terms

• Septic Shock Hyperdynamic
• Shock
• Shock, Septic

Intervention

Drug:
• Fluid resuscitation
Use the choice of crystalloid for resuscitation during the first 72 hours after enrollment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

References & 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. — View Citation

Peters E, Antonelli M, Wittebole X, Nanchal R, François 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 w — View Citation

Raghunathan K, Shaw A, Nathanson B, Stürmer 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 — View 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 Res — View 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. — View 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/j — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major adverse renal events in 28 days	Incidence of major adverse renal events	28 day
Secondary	Incidence of kidney injury	Incidence of kidney injury	28 day
Secondary	Serum creatinine(umol/L)	serum creatinine(umol/L)	28 day