Low Cardiac OutputPhase 3NCT00529711
The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients
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
Previous clinical trials with 11.2% Hypertonic Ringer's Lactate in post-operative CABG subjects have shown an increase in several cardiac performance parameters, with lesser volume of resuscitation fluid required to reach circulation volume, as compared to Sodium Chloride.It also does not cause hyperchloremic… Read more about this study
- Who is it for?
- Ages 45 to 80 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
- 66 participants
- Where
- 1 siteIndonesia
- Study dates
- Jul 2005to Jul 2006
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- 45 to 80 years
- CABG patients with on or off pump procedure
- Ejection fraction < 50%
- Given informed consent
Who cannot join
- Combined operations
- Severe arrhythmia(VT, AF rapid response, heart blocks) and severe hemodynamic imbalance
- Severe bleeding and/or re-operation
- Hypernatremia > 155 mMol/L
- Severe liver failure(SGOT, SGPT 2x normal)
- Severe renal failure(Creatinine > 2 mg. %)
- Major diseases(eg. cancer)
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, 114210
About this study
Previous clinical trials with 11.2% Hypertonic Ringer's Lactate in post-operative CABG subjects have shown an increase in several cardiac performance parameters, with lesser volume of resuscitation fluid required to reach circulation volume, as compared to Sodium Chloride.It also does not cause hyperchloremic acidosis, which is of value in treating shock patients.
The primary objectives of this prospective, randomized, open-label trial are to evaluate the clinical efficacy of hypertonic lactate in comparison to Ringer's lactate to maintain hemodynamic stability in intra- and post-CABG subjects in relation to hemodynamic status and body fluid balance, as well as to assess its safety in terms of lab parameters and occurrence of adverse events.The secondary objectives are to evaluate comparative clinical efficacy of the two fluids in relation to reduction in concomitant drug utilization, duration of ventilator usage, length of stay in ICU as well as total duration of hospitalization and neurocognitive status upto a period of 1 year post-CABG.
Read the detailed description
Details provided in summary.
- Conditions
- Low Cardiac Output
- Being tested
- Hypertonic lactate, Ringer's lactate
- Keywords
- coronary, artery, bypass, grafting, IV, 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
Solution given parenterally as follows:
Intraoperative 3 ml./kg BW for 15 minutes at beginning of surgery; During surgery 1.5 ml/kg BW/hour; Second loading 1.5 ml/kg BW for 15 minutes after protamin administration; Post-operative 1 ml/kg BW/hour for 12 hours.
Ringer's lactateDrug
Solution given parenterally as follows:
Intraoperative 3 ml./kg BW for 15 minutes at beginning of surgery; During surgery 1.5 ml/kg BW/hour; Second loading 1.5 ml/kg BW for 15 minutes after protamin administration; Post-operative 1 ml/kg BW/hour for 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Hypertonic lactate Receives: Drug: Hypertonic lactate |
| Group 2 | 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 status
Measured: During and 12 hours after CABG surgery
Secondary outcomes (1)
Safety of hypertonic sodium lactate for maintaining hemodynamic stability
Measured: During and 12 hours after 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 startJul 2005
- Study completionJul 2006
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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innogene Kalbiotech Pte. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Xavier Leverve, MD, PhD, Principal investigator, Director, INSERM-E0221-Bioenergetique Fondamentale et appliquee, Universite Joseph Fourier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529711
- Sponsor's protocol ID
- 001/IGK-KAL/DNA/04
- 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 of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients
- ClinicalTrials.gov ID
- NCT00529711
- Acronym / sponsor ID
- 001/IGK-KAL/DNA/04
- Conditions
- Low Cardiac Output
- Keywords
- coronary, artery, bypass, grafting, IV, cardiac output
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Innogene Kalbiotech Pte. LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Jul 2006 (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.
Previous clinical trials with 11.2% Hypertonic Ringer's Lactate in post-operative CABG subjects have shown an increase in several cardiac performance parameters, with lesser volume of resuscitation fluid required to reach circulation volume, as compared to Sodium Chloride.It also does not cause hyperchloremic acidosis, which is of value in treating shock patients.
The primary objectives of this prospective, randomized, open-label trial are to evaluate the clinical efficacy of hypertonic lactate in comparison to Ringer's lactate to maintain hemodynamic stability in intra- and post-CABG subjects in relation to hemodynamic status and body fluid balance, as well as to assess its safety in terms of lab parameters and occurrence of adverse events.The secondary objectives are to evaluate comparative clinical efficacy of the two fluids in relation to reduction in concomitant drug utilization, duration of ventilator usage, length of stay in ICU as well as total duration of hospitalization and neurocognitive status upto a period of 1 year post-CABG.
Detailed description
Details provided in summary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Hypertonic lactateHypertonic lactate |
| Group 2 | Active comparator | Drug: Ringer's lactateRinger's lactate |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female
- 45 to 80 years
- CABG patients with on or off pump procedure
- Ejection fraction < 50%
- Given informed consent
Key exclusion criteria (7 listed)
- Combined operations
- Severe arrhythmia(VT, AF rapid response, heart blocks) and severe hemodynamic imbalance
- Severe bleeding and/or re-operation
- Hypernatremia > 155 mMol/L
- Severe liver failure(SGOT, SGPT 2x normal)
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: TotilacSolution given parenterally as follows: Intraoperative 3 ml./kg BW for 15 minutes at beginning of surgery; During surgery 1.5 ml/kg BW/hour; Second loading 1.5 ml/kg BW for 15 minutes after protamin administration; Post-operative 1 ml/kg BW/hour for 12 hours. | Drug | Group 1 |
| Ringer's lactateSolution given parenterally as follows: Intraoperative 3 ml./kg BW for 15 minutes at beginning of surgery; During surgery 1.5 ml/kg BW/hour; Second loading 1.5 ml/kg BW for 15 minutes after protamin administration; Post-operative 1 ml/kg BW/hour for 12 hours. | Drug | Group 2 |
Primary outcome
Hemodynamic status
Time frame: During and 12 hours after CABG surgery
1 secondary outcome
Safety of hypertonic sodium lactate for maintaining hemodynamic stability
Time frame: During and 12 hours after 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.
Xavier Leverve, MD, PhD principal investigator
Director, INSERM-E0221-Bioenergetique Fondamentale et appliquee, Universite 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 5 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 status (time frame: During and 12 hours after 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.