Status:
COMPLETED
Bicarbonate and Lipocalin in Systemic Inflammatory Response Syndrome (SIRS) Study
Lead Sponsor:
Austin Health
Conditions:
Systemic Inflammatory Response Syndrome
Oliguria
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00706771
Start Date
February 1 2010
End Date
September 1 2012
Last Update
June 30 2014
Active Locations (2)
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1
Austin Hospital
Heidelberg, Melbourne, Victoria, Australia, 3084
2
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3154