NCT00706771

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2008

Completed
1.6 years until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

June 30, 2014

Status Verified

June 1, 2014

Enrollment Period

2.6 years

First QC Date

June 26, 2008

Last Update Submit

June 26, 2014

Conditions

Systemic Inflammatory Response SyndromeOliguriaRenal Impairment

Keywords

sodium bicarbonateserum neutrophil gelatinase associated lipocalinrenal impairmentrenal failuresystemic inflammatory response syndromedefinedby serum NGAL ≥ 100 ng/ml.

Outcome Measures

Primary Outcomes (1)

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

    28 days

Secondary Outcomes (3)

  • 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

Study Arms (2)

Sodium bicarbonate

ACTIVE COMPARATOR

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

Drug: Sodium bicarbonate

Sodium chloride

ACTIVE COMPARATOR

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

Drug: Sodium chloride

Interventions

Sodium bicarbonateDRUG

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

Sodium bicarbonate
Sodium chlorideDRUG

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

Sodium chloride

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Austin Hospital

Heidelberg, Melbourne, Victoria, 3084, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, 3154, Australia

Location

MeSH Terms

Conditions

Systemic Inflammatory Response SyndromeOliguriaRenal Insufficiency

Interventions

Sodium BicarbonateSodium Chloride

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsKidney Diseases

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsChloridesHydrochloric AcidChlorine Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Intensive Care Research

Study Record Dates

First Submitted

June 26, 2008

First Posted

June 30, 2008

Study Start

February 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

June 30, 2014

Record last verified: 2014-06

Locations

AU(2)