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

Austin Health70 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Systemic Inflammatory Response Syndrome Oliguria Renal Impairment

Interventions

Sodium bicarbonateDRUG

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

Sodium chlorideDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Austin Hospital

Heidelberg, Melbourne, Victoria, Australia

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

The ability to deliver the study protocol safely and rapidly with a trend to improved renal outcomes

Time frame: 28 days

Secondary Outcomes

Attenuation in lipocalin levels

Time frame: 28 days

Decrease in the magnitude in serum creatinine rise

Time frame: 28 days

Ability to deliver the study protocol without significant biochemical side effects

Time frame: 28 days

Data from ClinicalTrials.gov

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