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

NCT ID: NCT00706771

Last Updated: 2014-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-09-30

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.

Conditions

Systemic Inflammatory Response Syndrome; Oliguria; Renal Impairment

Study Design

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

Study Groups

Sodium bicarbonate

sodium bicarbonate: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr

Group Type: ACTIVE_COMPARATOR

Sodium bicarbonate

Intervention Type: DRUG

Sodium bicarbonate: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr

Sodium chloride

sodium chloride: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr

Group Type: ACTIVE_COMPARATOR

Sodium chloride

Intervention Type: DRUG

0.9% sodium chloride: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr

Interventions

Sodium bicarbonate

Sodium bicarbonate: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr

Intervention Type: DRUG

Sodium chloride

0.9% sodium chloride: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr

Intervention Type: DRUG

Eligibility Criteria

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

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

Sponsors

Austin Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Rinaldo Bellomo

Director of Intensive Care Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael C Reade, MBBS DPhil

Role: PRINCIPAL_INVESTIGATOR

Austin & Northern Hospitals, University of Melbourne

Nerina Harley, MBBS FCICM

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Rinaldo Bellomo, MD FJFICM

Role: PRINCIPAL_INVESTIGATOR

Austin Hospital, University of Melbourne

Locations

Austin Hospital

Heidelberg, Melbourne, Victoria, Australia

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

TNH 18/08

Identifier Type: -

Identifier Source: org_study_id