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

NCT00706771 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2014-06-30

No results posted yet for this study

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).

Conditions

  • Systemic Inflammatory Response Syndrome
  • Oliguria
  • Renal Impairment

Interventions

DRUG

Sodium bicarbonate

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

DRUG

Sodium chloride

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

Sponsors & Collaborators

  • Austin Health

    lead OTHER_GOV

Principal Investigators

  • Michael C Reade, MBBS DPhil · Austin & Northern Hospitals, University of Melbourne

  • Nerina Harley, MBBS FCICM · Melbourne Health

  • Rinaldo Bellomo, MD FJFICM · Austin Hospital, University of Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00706771 on ClinicalTrials.gov