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

A Randomized Double-blind Controlled Pilot Feasibility and Safety Trial of NGAL-directed Sodium Bicarbonate to Protect Renal Function in Patients With the Systemic Inflammatory Response Syndrome, Oliguria and Elevated Lipocalin Levels

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00706771

Acronym

BLISS

Enrollment

Registered

2008-06-30

Start date

2010-02-28

Completion date

2012-09-30

Last updated

2014-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oliguria, Renal Impairment, Systemic Inflammatory Response Syndrome

Keywords

sodium bicarbonate, serum neutrophil gelatinase associated lipocalin, renal impairment, renal failure, systemic inflammatory response syndrome, defined, by serum NGAL ≥ 100 ng/ml.

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 response syndrome, and low urine output or early acute renal impairment as defined by serum neutrophil gelatinase-associated lipocalin (NGAL).

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. 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.

Interventions

DRUGSodium bicarbonate

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

DRUGSodium chloride

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The ability to deliver the study protocol safely and rapidly with a trend to improved renal outcomes	28 days

Secondary

Measure	Time frame
Attenuation in lipocalin levels	28 days
Decrease in the magnitude in serum creatinine rise	28 days
Ability to deliver the study protocol without significant biochemical side effects	28 days

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026