Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats

NCT00529490 | Completed Phase 3

• 1 other identifier: 001/CT-KB/DNA/02
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible received either hypertonic lactate solution or Ringer's Lactate post-CABG in the ICU when fluid resuscitation was needed.

Conditions

Low Cardiac Output

Keywords

coronary; artery; bypass; grafting; I.V.; cardiac output

Outcome Measures

Primary Outcomes (1)

• hemodynamic stability

  12 hours post-CABG surgery

Secondary Outcomes (1)

• Safety of hypertonic sodium lactate for maintaining the hemodynamic stability

  12 hours post-CABG surgery

Study Arms (2)

HL

EXPERIMENTAL

Hypertonic lactate group

Drug: Hypertonic lactate

RL

ACTIVE COMPARATOR

Ringer's lactate

Drug: Ringer's lactate

Interventions

Hypertonic lactate DRUG

Parenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG

Also known as: Totilac

HL

Ringer's lactate DRUG

Parenteral solution administered to a maximal dose of 30 ml/kg BW over the first 12 hours post-CABG

RL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have given their written informed consent.
• Male or female, aged 18-75 years.
• Post-operative CABG on pump or off pump in ICU.
• Patients who need fluid resuscitation.

You may not qualify if:

• Combined operations.
• Need for intra aortic balloon pump (IABP).
• Patients with severe arrhythmia (VT, AF rapid response, heart block).
• Severe hemodynamic imbalance.
• Severe bleeding and/or re-operation.
• Liver dysfunction(SGOT and SGPT 2x normal).
• Renal failure (Creatinine \>2 mg%).

Sponsors & Collaborators

• Innogene Kalbiotech Pte. Ltd: lead

Study Sites (1)

National Cardiac Center, Department of Surgery and Intensive Care Unit, Harapan Kita Hospital

Jakarta, Jakarta Special Capital Region, Indonesia

Location

MeSH Terms

Conditions

Cardiac Output, Low

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Iqbal Mustafa, MD

  National cardiac Centre, Harapan Kita Hospital, Dept. of Anaesthesiology, Intensive Care Unit, Jakarta, Indonesia

  PRINCIPAL INVESTIGATOR

• Xavier Leverve, MD, PhD

  Director, INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université, Joseph Fourier, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2007
• First Posted: September 14, 2007
• Study Start: March 1, 2002
• Study Completion: June 1, 2003
• Last Updated: September 14, 2007

Record last verified: 2007-09

Locations

ID (1)