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

NCT01654653 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-08-01

No results posted yet for this study

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

Interventions

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.

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

Sponsors & Collaborators

  • Innogene Kalbiotech Pte. Ltd

    lead INDUSTRY

Principal Investigators

  • Cindy E Boom, PhD, MD · National Cardiovascular Center Harapan Kita, Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01654653 on ClinicalTrials.gov