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

NCT ID: NCT03277677

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2021-03-01

Brief 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.

Conditions

Sepsis; Septic Shock; Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

normal saline

Group Type: ACTIVE_COMPARATOR

Normal saline

Intervention Type: DRUG

for resuscitation in sepsis patients

balanced solution

Group Type: ACTIVE_COMPARATOR

Ringer's Acetate

Intervention Type: DRUG

for resuscitation in sepsis patients

Interventions

Normal saline

for resuscitation in sepsis patients

Intervention Type: DRUG

Ringer's Acetate

for resuscitation in sepsis patients

Intervention Type: DRUG

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Nattachai Srisawat ,M.D.

Associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chulalongkorn university

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

IRB.113/60

Identifier Type: -

Identifier Source: org_study_id