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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Innogene Kalbiotech Pte. Ltd
ClinicalTrials.gov Identifier:
NCT01654653
First received: May 3, 2012
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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).


Condition Intervention Phase
Coronary Heart Disease
Drug: Hypertonic sodium lactate
Drug: 6% Hydroxy Ethyl Starch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Innogene Kalbiotech Pte. Ltd:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    • Evaluation of efficacy of Hypertonic Sodium Lactate against 6% HES to maintain hemodynamic stability in intra CABG patients:

    1. Hemodynamic status (CI, MAP, PVR/PVRI, SVR/SVRI, CVP, PAM, PAW, HR).
    2. 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).

  • 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 ] [ Designated as safety issue: Yes ]

    Assess safety of HSL in intra CABG patients:

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


Enrollment: 100
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HSL(Totilac)
Hypertonic Sodium Lactate
Drug: Hypertonic sodium lactate
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 Name: Totilac
Active Comparator: 6% HES (Voluven)
6% Hydroxyethyl Starch
Drug: 6% Hydroxy Ethyl Starch
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 Name: Voluven

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654653

Locations
Indonesia
National Cardiovascular Center Harapan Kita
Jakarta, Indonesia, 11420
Sponsors and Collaborators
Innogene Kalbiotech Pte. Ltd
Investigators
Principal Investigator: Cindy E Boom, PhD, MD National Cardiovascular Center Harapan Kita, Indonesia
  More Information

No publications provided

Responsible Party: Innogene Kalbiotech Pte. Ltd
ClinicalTrials.gov Identifier: NCT01654653     History of Changes
Other Study ID Numbers: LB.05.01.1.4.0.70
Study First Received: May 3, 2012
Last Updated: July 27, 2012
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by Innogene Kalbiotech Pte. Ltd:
Heart disease
cardiac surgery
CABG
Totilac
Voluven
6% HES

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014