Overview

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

Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Austin Health
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