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

Renal Impairment Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706771
• Other study ID #: TNH 18/08
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2008
• Last updated: June 26, 2014
• Start date: February 2010
• Est. completion date: September 2012

Study information

• Verified date: June 2014
• Source: Austin Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oliguria
• Renal Impairment
• Renal Insufficiency
• Syndrome
• Systemic Inflammatory Response Syndrome

Intervention

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

Locations

Country	Name	City	State
Australia	Austin Hospital	Heidelberg, Melbourne	Victoria
Australia	Royal Melbourne Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Austin Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ability to deliver the study protocol safely and rapidly with a trend to improved renal outcomes		28 days	Yes
Secondary	Attenuation in lipocalin levels		28 days	No
Secondary	Decrease in the magnitude in serum creatinine rise		28 days	No
Secondary	Ability to deliver the study protocol without significant biochemical side effects		28 days	No