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Completed

NCT Number: NCT00706771

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Austin Hospital, Heidelberg, Melbourne, Victoria, Australia

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About this study

The investigators hypothesise:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium bicarbonate

Drug

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

Sodium Chloride

Drug

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

Primary outcomes

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

    Time frame: 28 days

Secondary outcomes

  1. Attenuation in lipocalin levels

    Time frame: 28 days

  2. Decrease in the magnitude in serum creatinine rise

    Time frame: 28 days

  3. Ability to deliver the study protocol without significant biochemical side effects

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Austin Health

Other Gov

Registry information

Official study title

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

Acronym: BLISS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 30, 2008
Registry last updated
Jun 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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