Clinical trial NCT00706771: Bicarbonate and Lipocalin in Systemic Inflammatory Response Syndrome (SIRS) Study
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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.
Lead sponsor: Austin Health
Sponsor class: OTHER_GOV
First posted: 2008-06-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The ability to deliver the study protocol safely and rapidly with a trend to improved renal outcomes
timeFrame: 28 days
Secondary outcomes:
measure: Attenuation in lipocalin levels
timeFrame: 28 days
measure: Decrease in the magnitude in serum creatinine rise
timeFrame: 28 days
measure: Ability to deliver the study protocol without significant biochemical side effects
timeFrame: 28 days
Other outcomes:
Locations:
city: Heidelberg, Melbourne
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Austin & Northern Hospitals, University of Melbourne
name: Michael C Reade, MBBS DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: Melbourne Health
name: Nerina Harley, MBBS FCICM
role: PRINCIPAL_INVESTIGATOR
affiliation: Austin Hospital, University of Melbourne
name: Rinaldo Bellomo, MD FJFICM
role: PRINCIPAL_INVESTIGATOR
References: