The Effect of Fluid Resuscitation With 0.9% Sodium Chloride Versus Balanced Crystalloid Solution on Renal Function of Sepsis Patients

Sepsis Clinical Trial

Official title:

The Effect of Fluid Resuscitation With 0.9% Sodium Chloride Versus Balanced Crystalloid Solution on Renal Function of Sepsis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03277677
• Other study ID #: IRB.113/60
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2017
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The high chloride content of 0.9%sodium chloride (0.9%NaCl) leads to adverse pathophysiological effects in both animals and healthy human volunteers. Small randomized trials confirm that the hyperchloremic acidosis induced by 0.9%NaCl also occurs in patients. A strong signal is emerging from recent large propensity-matched and cohort studies for the adverse effects that 0.9% NaCl has on the clinical outcome in surgical and critically ill patients when compared with balanced crystalloids. Major complications are the increased incidences of acute kidney injury and the need for renal replacement therapy, and that pathological hyperchloremia may increase postoperative mortality.

Fluid resuscitation with 0.9% NaCl in animals with sepsis resulted in hyperchloremic metabolic acidosis, worsened AKI, and increased mortality when compared with resuscitation with a balanced crystalloid solution.

Furthermore, hyperchloremic acidosis also resulted in increased concentrations of circulating inflammatory mediators in an experimental model of severe sepsis in rats, with a dose-dependent increase in circulating interleukin-6, tumor necrosis factor-a, and interleukin-10 concentrations with increasing acidosis.

Thus, in this study, investigators compared the effects of a balanced crystalloid solution with 0.9% NaCl on the renal function in severe sepsis/septic shock patients. Investigators hypothesized that balanced crystalloid solution resuscitation would decrease AKI incidence and severity and would improve immunomodulatory effect when compared with 0.9% NaCl resuscitation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: March 1, 2021
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age = 18 years old

• Who need fluid resuscitation in the Emergency Room (ER).

• Who have fulfilled the criteria for sepsis/septic shock within the previous 24 hours according to sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.

o Patients with infection and resulted from a host's systemic inflammatory response syndrome (SIRS) to infection are defined as sepsis if meet the criteria 2 or more of

• Temperature >38°C or <36°C

• Heart rate >90/min

• Respiratory rate >20/min or PaCo2 <32 mm Hg (4.3 kPa)

• White blood cell count >12000/mm3 or <4000/mm3 or >10% immature bands.

• Patient who have Septic shock is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality.

o Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP =65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation.

• AND where informed consent is obtainable either from the patient or by proxy (first degree relative, spouse) if patients aren't in fully conscious status (eg.comatose, drowsiness, irritable).

Exclusion criteria

Exclusion Criteria:

• Patients with chronic kidney disease (CKD) defined by baseline serum creatinine > 2.0 in male and 1.5 in female.

• Patients with End stage renal disease (ESRD) with or without renal replacement therapy.

• Patients with active cardiac disease : severe valvular heart, cardiomyopathy, decompensated heart failure NYHA II-IV, severe pulmonary hypertension.

• HIV/AIDs Patients.

• Allergy towards 0.9% NaCl or Ringer's Acetate.

• Any form of renal replacement therapy.

• Intracranial bleeding within current hospitalization.

• Therapy with corticosteroid or non steroidal anti-inflammatory substance.

• Patients who predicted not to survive more than 24 hours.

• Pregnant and lactating patients.

• Withdrawal of active therapy.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Sepsis
• Septic Shock
• Toxemia

Intervention

Drug:
• Normal saline
for resuscitation in sepsis patients
• Ringer's Acetate
for resuscitation in sepsis patients

Locations

Country	Name	City	State
Thailand	Chulalongkorn university	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of acute kidney injury for any stage and severity		at day 7
Secondary	The neutrophil function (chemotaxis, CD11b ) between two randomized groups at		0, 24, and 72 hours after resuscitation.
Secondary	The monocyte function (HLA-DR) between two randomized groupsafter resuscitation.		at 0, 24, and 72 hours after resuscitation.
Secondary	The inflammatory marker (IL-6, IL-10) between two randomized groups at		0, 24, and 72 hours after resuscitation.
Secondary	Urinary neutrophil gelatinase-associated lipocalin (NGAL) after randomization and after resuscitation with trial fluid		at 0,24 and 72 hours after resuscitation.
Secondary	Urinary liver-type fatty acid binding protein (L-FABP)		at 0,24 and 72 hours after resuscitation.
Secondary	Sequential [Sepsis-related] Organ Failure Assessment (SOFA) Score. (excluding Glasgow Coma Score) at 72 hours after randomization.		at 72 hours after randomization.
Secondary	Need of renal replacement therapy within 72 hours after randomization		within 72 hours after randomization
Secondary	Days alive without renal replacement therapy		in 28 days after randomization
Secondary	Hospital length of stay for survivors sanctioned		at 28 days after randomization