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

Innogene Kalbiotech

Status and phase: Completed; Phase 3

Conditions: Low Cardiac Output

Treatments: Drug: Hypertonic lactate; Drug: Ringer's lactate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00529490

001/CT-KB/DNA/02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 230 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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%).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

HL

Experimental group

Description:

Hypertonic lactate group

Treatment:

Drug: Hypertonic lactate

RL

Active Comparator group

Description:

Ringer's lactate

Treatment:

Drug: Ringer's lactate