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

Austin Health

Status and phase: Completed; Phase 2

Conditions: Renal Impairment; Oliguria; Systemic Inflammatory Response Syndrome

Treatments: Drug: Sodium bicarbonate; Drug: Sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00706771

TNH 18/08

Details and patient eligibility

About

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).

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

Sodium bicarbonate

Active Comparator group

Description:

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

Treatment:

Drug: Sodium bicarbonate

Sodium chloride

Active Comparator group

Description:

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

Treatment:

Drug: Sodium chloride