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NCT Number: NCT01654653

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

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).

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Cardiovascular Center Harapan Kita

Jakarta, Jakarta Special Capital Region, 11420, Indonesia

About this study

The primary objectives of this prospective, randomized and open-label study are as follows:

  • To evaluate the clinical efficacy of Hypertonic Sodium Lactate (HSL) in comparison with 6% HES to maintain hemodynamic stability in intra CABG patients related to hemodynamic status and Body fluid balance.
  • To assess the safety of HSL in intra CABG patients related to defined laboratory parameters clinical adverse events which occur during the trial.

Subjects meeting enrolment criteria will be randomly assigned to HSL or 6%HES treatment groups.

Assessment of comparability will be done by unpaired student t-test or Chi-Square test or by a two-way ANOVA for repeated measures followed by post-hoc analysis when significant difference is found within the two groups.

The hypothesis tested is that HSL is effective in intra CABG surgery patients, requiring less volume with better cardiac index, as compared to 6% HES.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypertonic sodium lactate

Drug

Administered at beginning of surgery as loading dose at 3 mL/kg body weight within 15 minutes. Additional fluid administered if needed and this was was managed similarly in both groups; the types and amount of additional fluid was measured and recorded. Surgery procedure and concomitant medication was managed similarly.

Other names: Totilac

6% Hydroxy Ethyl Starch

Drug

Administered at beginning of surgery as loading dose at 3 mL/kgBW within 15 minutes. Additional fluid given if needed and this was managed similarly in both groups; the types and amount of additional fluid was measured and recorded. Surgery procedure and concomitant medication was managed similarly

Other names: Voluven

Primary outcomes

  1. Efficacy

    Time frame: Assessed from baseline till upto end of surgery(mean duration of surgery was 372.47 ± 122.82 min in HSLgroup vs 380.61 ± 82.08 min in HES group

    • Evaluation of efficacy of Hypertonic Sodium Lactate against 6% HES to maintain hemodynamic stability in intra CABG patients:
    • Hemodynamic status (CI, MAP, PVR/PVRI, SVR/SVRI, CVP, PAM, PAW, HR).
    • Body fluid balance (urinary output; total fluid loss including urine and hemorrhage; total fluid infusion including HSL and 6% HES, blood product and other fluids).

  2. Safety

    Time frame: Assessed from baseline till upto end of surgery(mean duration of surgery was 372.47 ± 122.82 min in HSLgroup vs 380.61 ± 82.08 min in HES group

    Assess safety of HSL in intra CABG patients:

    • Lab parameters: Hb, HCT, Na,K, Cl, Mg, lactate, glucose, and arterial blood gas.
    • Adverse events

Sponsors and collaborators

Lead sponsor

Innogene Kalbiotech Pte. Ltd

Industry

Registry information

Official study title

A Phase , Prospective, Randomized, Open-label Study to Compare the Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG (Coronary Artery Bypass Grafting) Patients

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 1, 2012
Registry last updated
Aug 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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