Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG Patients

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The choice of fluid therapy is controversial in cardiac surgery. Numerous studies have shown that colloid is better as compared to crystalloids. Several previous studies have demonstrated that Hypertonic Sodium Lactate (HSL) administration during cardiac surgery shows a promising effect. This study aims to compare hemodynamic effects and fluid balance of HSL with 6% Hydroxy Ethyl Starch (HES).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innogene Kalbiotech Pte. Ltd

Criteria

Inclusion Criteria:

• Male or female, aged 45-80 years.

• CABG patients with on or off pump procedure.

• Ejection fraction <50%

• Patients who have given their written informed consent.

Exclusion Criteria:

• Combined operations(surgeries)

• Patients with severe arrhythmia (VT, AF rapid response, heart block) and severe hemodynamic imbalance.

• Severe bleeding and/or re-operation.

• Hypernatremia> 155 mmol/L

• Severe liver failure: SGOT and SGPT more than twice normal.

• Severe renal failure: creatinine more than 2 mg%.

• Patients with major diseases such as cancer, etc.