Low Cardiac OutputPhase 3NCT00529490
Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats
A Phase 3 study testing Hypertonic lactate and Ringer's lactate in people with Low Cardiac Output, run by Innogene Kalbiotech Pte. Ltd at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Cardiac Output
- What is being tested?
- Hypertonic lactate and Ringer's lactate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteIndonesia
- Study dates
- Mar 2002to Jun 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%).
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
National Cardiac Center, Department of Surgery and Intensive Care Unit, Harapan Kita Hospital
Jakarta, Jakarta Special Capital Region
About this study
Official title: The Efficacy and Safety of Hypertonic Lactate Solution as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG (Coronary Artery Bypass Grafting) Patients
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.
Read the 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.
- Conditions
- Low Cardiac Output
- Being tested
- Hypertonic lactate, Ringer's lactate
- Keywords
- coronary, artery, bypass, grafting, I.V., cardiac output
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic lactateDrug
Also called Totilac
Parenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG
Ringer's lactateDrug
Parenteral solution administered to a maximal dose of 30 ml/kg BW over the first 12 hours post-CABG
| Study group | Role | What they receive |
|---|---|---|
| HL | Experimental | Hypertonic lactate group Receives: Drug: Hypertonic lactate |
| RL | Active comparator | Ringer's lactate Receives: Drug: Ringer's lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic stability
Measured: 12 hours post-CABG surgery
Secondary outcomes (1)
Safety of hypertonic sodium lactate for maintaining the hemodynamic stability
Measured: 12 hours post-CABG surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startMar 2002
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Cardiac OutputStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innogene Kalbiotech Pte. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Iqbal Mustafa, MD, Principal investigator, National cardiac Centre, Harapan Kita Hospital, Dept. of Anaesthesiology, Intensive Care Unit, Jakarta, IndonesiaXavier Leverve, MD, PhD, Principal investigator, Director, INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université, Joseph Fourier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529490
- Sponsor's protocol ID
- 001/CT-KB/DNA/02
- Status last verified
- Sep 2007
- First submitted
- 12 Sep 2007
- Last updated
- 14 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Hypertonic Lactate Solution as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG (Coronary Artery Bypass Grafting) Patients
- ClinicalTrials.gov ID
- NCT00529490
- Acronym / sponsor ID
- 001/CT-KB/DNA/02
- Conditions
- Low Cardiac Output
- Keywords
- coronary, artery, bypass, grafting, I.V., cardiac output
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Innogene Kalbiotech Pte. LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Study completion
- Jun 2003 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HL | Experimental | Drug: Hypertonic lactateHypertonic lactate group |
| RL | Active comparator | Drug: Ringer's lactateRinger's lactate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertonic lactateAlso: TotilacParenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG | Drug | HL |
| Ringer's lactateParenteral solution administered to a maximal dose of 30 ml/kg BW over the first 12 hours post-CABG | Drug | RL |
Primary outcome
hemodynamic stability
Time frame: 12 hours post-CABG surgery
1 secondary outcome
Safety of hypertonic sodium lactate for maintaining the hemodynamic stability
Time frame: 12 hours post-CABG surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iqbal Mustafa, MD principal investigator
National cardiac Centre, Harapan Kita Hospital, Dept. of Anaesthesiology, Intensive Care Unit, Jakarta, Indonesia
Xavier Leverve, MD, PhD principal investigator
Director, INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université, Joseph Fourier, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypertonic lactate and Ringer's lactate in people with Low Cardiac Output, run by Innogene Kalbiotech Pte. Ltd at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemodynamic stability (time frame: 12 hours post-CABG surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2007.