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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00706771
Recruitment Status : Completed
First Posted : June 30, 2008
Last Update Posted : June 30, 2014
Sponsor:
Information provided by (Responsible Party):
Rinaldo Bellomo, Austin Health

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).

Condition or disease Intervention/treatment Phase
Systemic Inflammatory Response Syndrome Oliguria Renal Impairment Drug: Sodium bicarbonate Drug: Sodium chloride Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sodium bicarbonate
sodium bicarbonate: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr
Drug: Sodium bicarbonate
Sodium bicarbonate: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr

Active Comparator: Sodium chloride
sodium chloride: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr
Drug: Sodium chloride
0.9% sodium chloride: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr




Primary Outcome Measures :
  1. The ability to deliver the study protocol safely and rapidly with a trend to improved renal outcomes [ Time Frame: 28 days ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00706771


Locations
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Australia, Victoria
Austin Hospital
Heidelberg, Melbourne, Victoria, Australia, 3084
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3154
Sponsors and Collaborators
Austin Health
Investigators
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Principal Investigator: Michael C Reade, MBBS DPhil Austin & Northern Hospitals, University of Melbourne
Principal Investigator: Nerina Harley, MBBS FCICM Melbourne Health
Principal Investigator: Rinaldo Bellomo, MD FJFICM Austin Hospital, University of Melbourne
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Responsible Party: Rinaldo Bellomo, Director of Intensive Care Research, Austin Health
ClinicalTrials.gov Identifier: NCT00706771    
Other Study ID Numbers: TNH 18/08
First Posted: June 30, 2008    Key Record Dates
Last Update Posted: June 30, 2014
Last Verified: June 2014
Keywords provided by Rinaldo Bellomo, Austin Health:
sodium bicarbonate
serum neutrophil gelatinase associated lipocalin
renal impairment
renal failure
systemic inflammatory response syndrome
defined
by serum NGAL ≥ 100 ng/ml.
Additional relevant MeSH terms:
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Renal Insufficiency
Oliguria
Syndrome
Systemic Inflammatory Response Syndrome
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Inflammation
Shock
Urination Disorders
Urological Manifestations