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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).
The investigators hypothesise:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium bicarbonate | Active Comparator | sodium bicarbonate: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr |
|
| Sodium chloride | Active Comparator | sodium chloride: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate | Drug | Sodium bicarbonate: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr |
|
| Measure | Description | Time Frame |
|---|---|---|
| The ability to deliver the study protocol safely and rapidly with a trend to improved renal outcomes | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin Hospital | Heidelberg, Melbourne | Victoria | 3084 | Australia | ||
| Royal Melbourne Hospital |
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| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D009846 | Oliguria |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| Sodium chloride | Drug | 0.9% sodium chloride: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr |
|
| 28 days |
| Melbourne |
| Victoria |
| 3154 |
| Australia |
| D014555 |
| Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D007674 | Kidney Diseases |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |