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

The Efficacy and Safety of Hypertonic Lactate Solution as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG (Coronary Artery Bypass Grafting) Patients

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00529490
Enrollment
230
Registered
2007-09-14
Start date
2002-03-31
Completion date
2003-06-30
Last updated
2007-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Cardiac Output

Keywords

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

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.

Detailed description

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 observed in the first 12 hours in the ICU when fluid resuscitation was needed.

Interventions

DRUGHypertonic lactate

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

DRUGRinger's lactate

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

Sponsors

Innogene Kalbiotech Pte. Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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%).

Design outcomes

Primary

MeasureTime frame
hemodynamic stability12 hours post-CABG surgery

Secondary

MeasureTime frame
Safety of hypertonic sodium lactate for maintaining the hemodynamic stability12 hours post-CABG surgery

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026