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

NCT01654653 | Completed Phase 4

• 1 other identifier: LB.05.01.1.4.0.70
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Coronary Heart Disease

Keywords

Heart disease; cardiac surgery; CABG; Totilac; Voluven; 6% HES

Outcome Measures

Primary Outcomes (2)

• Efficacy

  • 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).

  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

• Safety

  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

  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

Study Arms (2)

HSL(Totilac)

EXPERIMENTAL

Hypertonic Sodium Lactate

Drug: Hypertonic sodium lactate

6% HES (Voluven)

ACTIVE COMPARATOR

6% Hydroxyethyl Starch

Drug: 6% Hydroxy Ethyl Starch

Interventions

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.

Also known as: Totilac

HSL(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

Also known as: Voluven

6% HES (Voluven)

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innogene Kalbiotech Pte. Ltd: lead

Study Sites (1)

National Cardiovascular Center Harapan Kita

Jakarta, Jakarta Special Capital Region, 11420, Indonesia

Location

MeSH Terms

Conditions

Coronary Disease; Heart Diseases

Interventions

HES 130-0.4

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Cindy E Boom, PhD, MD

  National Cardiovascular Center Harapan Kita, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: August 1, 2012
• Study Start: July 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

ID (1)