Bicarbonate and Lipocalin in Systemic Inflammatory Response Syndrome (SIRS) Study

Phase 2

Completed

• Conditions: Systemic Inflammatory Response Syndrome; Oliguria; Renal Impairment
• Interventions: Drug: Sodium bicarbonate; Drug: Sodium chloride

• Registration Number: NCT00706771
• Lead Sponsor: Austin Health

Brief Summary

The investigators will determine the feasibility, safety and efficacy of intravenous sodium bicarbonate in reducing progression to overt acute renal failure in patients with the systemic inflammatory response syndrome, and low urine output or early acute renal impairment as defined by serum neutrophil gelatinase-associated lipocalin (NGAL).

Detailed Description

The investigators hypothesise:

1. In patients with SIRS and oliguria the early administration of sodium bicarbonate or sodium chloride (control) triggered by an abnormally high NGAL level is feasible.

2. In patients with SIRS and oliguria the early administration of sodium bicarbonate or sodium chloride (control) triggered by an abnormally high NGAL level is safe.

3. In patients with SIRS and oliguria the early administration of sodium bicarbonate or sodium chloride (control) triggered by an abnormally high NGAL level leads to signs or trends of efficacy as measured by serum creatinine derived indices.

Study Timeline

• Study First Submitted: 2008-06-26
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-06-30
• Study Start: 2010-02
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-26
• Last Update Posted: 2014-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Consent obtained
• Diagnosis of SIRS. Requires any TWO of:

temperature > 38°C or < 36°C OR heart rate > 90 beats/min OR respiratory rate > 20 breaths/min. PaCO2 < 32 mm Hg OR alteration of white blood cell count > 12,000 cells/mm3, < 4,000 cells/mm3, or the presence of > 10% immature neutrophils

• elevated lipocalin level
• Arterial line already in place
• Central venous catheter already in place
• Age ≥ 18 years
• Within 24 hours of admission to the ICU

Exclusion Criteria

• Unlikely to remain in ICU for >72 hours
• Moribund patient
• Pre-existing CKD, transplant or ESRD
• Receiving (or about to receive) continuous renal replacement therapy for acute renal failure at time of enrolment
• Diagnosis of acute GN, AIN, vasculitis or post-renal aetiology
• Known/suspected study allergy to sodium bicarbonate
• Enrolling physician concern about patient enrolment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium bicarbonate	Sodium bicarbonate	sodium bicarbonate: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr
Sodium chloride	Sodium chloride	sodium chloride: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr

Primary Outcome Measures

Name	Time	Method
The ability to deliver the study protocol safely and rapidly with a trend to improved renal outcomes	28 days

Secondary Outcome Measures

Name	Time	Method
Attenuation in lipocalin levels	28 days
Decrease in the magnitude in serum creatinine rise	28 days
Ability to deliver the study protocol without significant biochemical side effects	28 days

Trial Locations

Locations (2)

Austin Hospital; 🇦🇺 Heidelberg, Melbourne, Victoria, Australia

Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia