Status:
COMPLETED
The Effect of Fluid Resuscitation With 0.9% Sodium Chloride Versus Balanced Crystalloid Solution on Renal Function of Sepsis Patients
Lead Sponsor:
Chulalongkorn University
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
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 hyperchlo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT03277677
Start Date
July 1 2017
End Date
March 1 2021
Last Update
March 9 2021
Active Locations (1)
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1
Chulalongkorn university
Bangkok, Thailand, 10330