search
Back to results

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

Primary Purpose

Systemic Inflammatory Response Syndrome, Oliguria, Renal Impairment

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Sodium bicarbonate
Sodium chloride
Sponsored by
Austin Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Inflammatory Response Syndrome focused on measuring sodium bicarbonate, serum neutrophil gelatinase associated lipocalin, renal impairment, renal failure, systemic inflammatory response syndrome, defined, by serum NGAL ≥ 100 ng/ml.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Austin Hospital
  • Royal Melbourne Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sodium bicarbonate

Sodium chloride

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2008
Last Updated
June 26, 2014
Sponsor
Austin Health
search

1. Study Identification

Unique Protocol Identification Number
NCT00706771
Brief Title
Bicarbonate and Lipocalin in Systemic Inflammatory Response Syndrome (SIRS) Study
Acronym
BLISS
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 Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Austin Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Inflammatory Response Syndrome, Oliguria, Renal Impairment
Keywords
sodium bicarbonate, serum neutrophil gelatinase associated lipocalin, renal impairment, renal failure, systemic inflammatory response syndrome, defined, by serum NGAL ≥ 100 ng/ml.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sodium bicarbonate
Arm Type
Active Comparator
Arm Description
sodium bicarbonate: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr
Arm Title
Sodium chloride
Arm Type
Active Comparator
Arm Description
sodium chloride: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate
Intervention Description
Sodium bicarbonate: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr
Intervention Type
Drug
Intervention Name(s)
Sodium chloride
Intervention Description
0.9% sodium chloride: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr
Primary Outcome Measure Information:
Title
The ability to deliver the study protocol safely and rapidly with a trend to improved renal outcomes
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Attenuation in lipocalin levels
Time Frame
28 days
Title
Decrease in the magnitude in serum creatinine rise
Time Frame
28 days
Title
Ability to deliver the study protocol without significant biochemical side effects
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael C Reade, MBBS DPhil
Organizational Affiliation
Austin & Northern Hospitals, University of Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nerina Harley, MBBS FCICM
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rinaldo Bellomo, MD FJFICM
Organizational Affiliation
Austin Hospital, University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Austin Hospital
City
Heidelberg, Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3154
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs