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| Name | Class |
|---|---|
| Innogene Kalbiotech Pte. Ltd | INDUSTRY |
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The objective of this trial to see whether:
-Cardiac performance (cardiac index and secondary outcomes)can be improved in patients with acute heart failure (AHF) and symptoms and consequences of fluid overload (pulmonary and interstitial edema) and poor peripheral perfusion can be reduced by:
Optimal standard treatment will be achieved in both arms with the use of current best treatment protocol for AHF as per independent treating physician.
4. To assess effects of 0.5M Na lactate (Totilac) on plasma and urine biological parameters (sodium, potassium, chloride, pH, bicarb, base excess, albumin)
5. To assess effects of 0.5M Na lactate on morbidity and mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5M Sodium lactate | Experimental | A bolus of 0.5M Sodium lactate of 3 ml per kg body weight (BW) is administered in 15 minutes, followed by a continuous infusion with 1 ml per kg per hour for 24 hours, i.e. in total 27 ml per kg over 24 hours |
|
| Hartmann's solution | Active Comparator | Hartmann's solution of 3 ml per kg BW is administered in 15 minutes. There is NO continuous infusion infused thereafter; i.e. in total 3 ml per kg over 24 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5M Sodium lactate | Drug | A bolus of 0.5M Sodium lactate of 3 ml per kg BW is administered in 15 minutes, followed by a continuous infusion with 1 ml per kg per hour for 24 hours, i.e. in total 27 ml per kg over 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Improvement in cardiac output measured by transthoracic echocardiography at 24 hours from initiation of study drug infusion | Baseline till 24 hours from first loading of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| mortality | range of efficacy and safety parameters | up to 3 month |
| acid base and electrolytes, fluid balance | the effect on on pH, base excess, bicarbonate, sodium, potassium, phosphate, chloride and lactate will be assessed during the study period |
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Inclusion Criteria:
Left heart failure: as evidenced by 2 out of 3:
Right heart failure: as evidenced by 1 out of 2:
Cold mottled skin Low urine output Acutely clouded sensorium/poor mentation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marek Nalos, MD | Dept. of Intensive Care, Nepean Hosp., U Sydney, Penrith, NSW, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Intensive Care, Nepean Hosp., U Sydney | Penrith | New South Wales | 2751 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24666826 | Derived | Nalos M, Leverve X, Huang S, Weisbrodt L, Parkin R, Seppelt I, Ting I, Mclean A. Half-molar sodium lactate infusion improves cardiac performance in acute heart failure: a pilot randomised controlled clinical trial. Crit Care. 2014 Mar 25;18(2):R48. doi: 10.1186/cc13793. |
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| ID | Term |
|---|---|
| D019354 | Sodium Lactate |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D007773 | Lactates |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Hartmann's solution | Drug | Hartmann's solution of 3 ml per kg BW is administered in 15 minutes, No infusion thereafter i.e. in total 3 ml per kg over 24 hours |
|
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| 48 hours |
| organ function | effect on respiratory function assessed by time on ventilatory support and renal function measured by creatinine level over 48 hours will be assessed | 48 hours |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |