Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats

Study Overview
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Brief Summary
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Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible received either hypertonic lactate solution or Ringer's Lactate post-CABG in the ICU when fluid resuscitation was needed.

Detailed Description
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Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible received either hypertonic lactate solution or Ringer's Lactate post-CABG observed in the first 12 hours in the ICU when fluid resuscitation was needed.

Official Title
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The Efficacy and Safety of Hypertonic Lactate Solution as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG (Coronary Artery Bypass Grafting) Patients

Conditions
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Low Cardiac Output

Intervention / Treatment
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* Drug: Hypertonic lactate
* Drug: Ringer's lactate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have given their written informed consent. Male or female, aged 18-75 years. Post-operative CABG on pump or off pump in ICU. Patients who need fluid resuscitation. Exclusion Criteria: Combined operations. Need for intra aortic balloon pump (IABP). Patients with severe arrhythmia (VT, AF rapid response, heart block). Severe hemodynamic imbalance. Severe bleeding and/or re-operation. Liver dysfunction(SGOT and SGPT 2x normal). Renal failure (Creatinine >2 mg%).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HL<br>Hypertonic lactate group | Drug: Hypertonic lactate<br>* Parenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG<br>* Other names: Totilac;|
| Active Comparator: RL<br>Ringer's lactate | Drug: Ringer's lactate<br>* Parenteral solution administered to a maximal dose of 30 ml/kg BW over the first 12 hours post-CABG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic stability |  | 12 hours post-CABG surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of hypertonic sodium lactate for maintaining the hemodynamic stability |  | 12 hours post-CABG surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary, artery, bypass, grafting, I.V., cardiac output