Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Austin Health |
---|---|
Information provided by: | Austin Health |
ClinicalTrials.gov Identifier: | NCT00706771 |
The investigators will determine the efficacy of intravenous sodium bicarbonate in reducing progression to overt acute renal failure in patients with low urine output, the systemic inflammatory response syndrome, and early acute renal impairment as defined by a new and experimental test of renal function, serum neutrophil gelatinase-associated lipocalin (NGAL).
Condition | Intervention | Phase |
---|---|---|
Systemic Inflammatory Response Syndrome Oliguria Renal Impairment |
Drug: Sodium bicarbonate Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Double-Blind Placebo-Controlled Pilot Trial of NGAL-Directed Sodium Bicarbonate to Protect Renal Function in Patients With the Systemic Inflammatory Response Syndrome and Oliguria |
Estimated Enrollment: | 170 |
Study Start Date: | February 2009 |
Arms | Assigned Interventions |
---|---|
Sodium bicarbonate: Active Comparator |
Drug: Sodium bicarbonate
Sodium bicarbonate: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr
|
Placebo: Placebo Comparator |
Drug: Placebo
0.9% sodium chloride
|
We hypothesise:
To test these hypotheses we have designed a protocol that simultaneously tests both NGAL as a diagnostic strategy and sodium bicarbonate as a therapeutic intervention.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
Exclusion Criteria:
Contact: Michael C Reade, MBBS DPhil | 39-496-5000 ext 4838 | michael.reade@austin.org.au |
Contact: Forbes McGain, MBBS FJFICM | 38-345-6666 | Forbes.McGain@wh.org.au |
Australia, Victoria | |
Northern Hospital | |
Epping, Victoria, Australia, 3076 | |
Austin Hospital | |
Heidelberg, Melbourne, Victoria, Australia, 3084 | |
Western Hospital | |
Footscray, Victoria, Australia |
Principal Investigator: | Michael C Reade, MBBS DPhil | Austin & Northern Hospitals, University of Melbourne |
Principal Investigator: | Forbes McGain, MBBS FJFICM | Western Hospital, University of Melbourne |
Principal Investigator: | Rinaldo Bellomo, MD FJFICM | Austin Hospital, University of Melbourne |
Responsible Party: | The Northern Hospital, Melbourne, Australia ( Associate Professor Michael C. Reade ) |
Study ID Numbers: | TNH 18/08 |
Study First Received: | June 26, 2008 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00706771 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
sodium bicarbonate serum neutrophil gelatinase associated lipocalin renal impairment renal failure |
systemic inflammatory response syndrome defined by serum NGAL ≥ 100 ng/ml. |
Systemic Inflammatory Response Syndrome Signs and Symptoms Shock Urologic Diseases |
Urination Disorders Oliguria Inflammation Kidney Failure |
Urological Manifestations Pathologic Processes Disease Syndrome |