Coronary Heart DiseasePhase 4NCT01654653
Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG Patients
A Phase 4 study testing Hypertonic sodium lactate and 6% Hydroxy Ethyl Starch in people with Coronary Heart Disease, run by Innogene Kalbiotech Pte. Ltd at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Hypertonic sodium lactate and 6% Hydroxy Ethyl Starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- Jul 2008to Mar 2009
- Phase
- Phase 4
- 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, aged 45-80 years.
- CABG patients with on or off pump procedure.
- Ejection fraction <50%
- Patients who have given their written informed consent.
Who cannot join
- Combined operations(surgeries)
- Patients with severe arrhythmia (VT, AF rapid response, heart block) and severe hemodynamic imbalance.
- Severe bleeding and/or re-operation.
- Hypernatremia> 155 mmol/L
- Severe liver failure: SGOT and SGPT more than twice normal.
- Severe renal failure: creatinine more than 2 mg%.
- Patients with major diseases such as cancer, etc.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
National Cardiovascular Center Harapan Kita
Jakarta, Jakarta Special Capital Region, 11420
About this study
Official title: A Phase , Prospective, Randomized, Open-label Study to Compare the Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG (Coronary Artery Bypass Grafting) Patients
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).
Read the detailed description
The primary objectives of this prospective, randomized and open-label study are as follows:
- To evaluate the clinical efficacy of Hypertonic Sodium Lactate (HSL) in comparison with 6% HES to maintain hemodynamic stability in intra CABG patients related to hemodynamic status and Body fluid balance.
- To assess the safety of HSL in intra CABG patients related to defined laboratory parameters clinical adverse events which occur during the trial.
Subjects meeting enrolment criteria will be randomly assigned to HSL or 6%HES treatment groups.
Assessment of comparability will be done by unpaired student t-test or Chi-Square test or by a two-way ANOVA for repeated measures followed by post-hoc analysis when significant difference is found within the two groups.
The hypothesis tested is that HSL is effective in intra CABG surgery patients, requiring less volume with better cardiac index, as compared to 6% HES.
- Conditions
- Coronary Heart Disease
- Being tested
- Hypertonic sodium lactate, 6% Hydroxy Ethyl Starch
- Keywords
- Heart disease, cardiac surgery, CABG, Totilac, Voluven, 6% HES
- Medical subject headings
- Coronary Disease, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic sodium lactateDrug
Also called Totilac
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.
6% Hydroxy Ethyl StarchDrug
Also called Voluven
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
| Study group | Role | What they receive |
|---|---|---|
| HSL(Totilac) | Experimental | Hypertonic Sodium Lactate Receives: Drug: Hypertonic sodium lactate |
| 6% HES (Voluven) | Active comparator | 6% Hydroxyethyl Starch Receives: Drug: 6% Hydroxy Ethyl Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
- Evaluation of efficacy of Hypertonic Sodium Lactate against 6% HES to maintain hemodynamic stability in intra CABG patients:
- Hemodynamic status (CI, MAP, PVR/PVRI, SVR/SVRI, CVP, PAM, PAW, HR).
- Body fluid balance (urinary output; total fluid loss including urine and hemorrhage; total fluid infusion including HSL and 6% HES, blood product and other fluids).
Measured: Assessed from baseline till upto end of surgery(mean duration of surgery was 372.47 ± 122.82 min in HSLgroup vs 380.61 ± 82.08 min in HES group
Safety
Assess safety of HSL in intra CABG patients:
- Lab parameters: Hb, HCT, Na,K, Cl, Mg, lactate, glucose, and arterial blood gas.
- Adverse events
Measured: Assessed from baseline till upto end of surgery(mean duration of surgery was 372.47 ± 122.82 min in HSLgroup vs 380.61 ± 82.08 min in HES group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innogene Kalbiotech Pte. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cindy E Boom, PhD, MD, Principal investigator, National Cardiovascular Center Harapan Kita, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654653
- Sponsor's protocol ID
- LB.05.01.1.4.0.70
- Status last verified
- Jul 2012
- First submitted
- 3 May 2012
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase , Prospective, Randomized, Open-label Study to Compare the Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG (Coronary Artery Bypass Grafting) Patients
- ClinicalTrials.gov ID
- NCT01654653
- Acronym / sponsor ID
- LB.05.01.1.4.0.70
- Conditions
- Coronary Heart Disease
- Keywords
- Heart disease, cardiac surgery, CABG, Totilac, Voluven, 6% HES
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Innogene Kalbiotech Pte. LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 1 Aug 2012 (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.
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).
Detailed description
The primary objectives of this prospective, randomized and open-label study are as follows:
- To evaluate the clinical efficacy of Hypertonic Sodium Lactate (HSL) in comparison with 6% HES to maintain hemodynamic stability in intra CABG patients related to hemodynamic status and Body fluid balance.
- To assess the safety of HSL in intra CABG patients related to defined laboratory parameters clinical adverse events which occur during the trial.
Subjects meeting enrolment criteria will be randomly assigned to HSL or 6%HES treatment groups.
Assessment of comparability will be done by unpaired student t-test or Chi-Square test or by a two-way ANOVA for repeated measures followed by post-hoc analysis when significant difference is found within the two groups.
The hypothesis tested is that HSL is effective in intra CABG surgery patients, requiring less volume with better cardiac index, as compared to 6% HES.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSL(Totilac) | Experimental | Drug: Hypertonic sodium lactateHypertonic Sodium Lactate |
| 6% HES (Voluven) | Active comparator | Drug: 6% Hydroxy Ethyl Starch6% Hydroxyethyl Starch |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged 45-80 years.
- CABG patients with on or off pump procedure.
- Ejection fraction <50%
- Patients who have given their written informed consent.
Key exclusion criteria (7 listed)
- Combined operations(surgeries)
- Patients with severe arrhythmia (VT, AF rapid response, heart block) and severe hemodynamic imbalance.
- Severe bleeding and/or re-operation.
- Hypernatremia> 155 mmol/L
- Severe liver failure: SGOT and SGPT more than twice 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 sodium lactateAlso: TotilacAdministered 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 | HSL(Totilac) |
| 6% Hydroxy Ethyl StarchAlso: VoluvenAdministered 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 | Drug | 6% HES (Voluven) |
Primary outcome
Efficacy
Time frame: Assessed from baseline till upto end of surgery(mean duration of surgery was 372.47 ± 122.82 min in HSLgroup vs 380.61 ± 82.08 min in HES group
• Evaluation of efficacy of Hypertonic Sodium Lactate against 6% HES to maintain hemodynamic stability in intra CABG patients: 1. Hemodynamic status (CI, MAP, PVR/PVRI, SVR/SVRI, CVP, PAM, PAW, HR). 2. Body fluid balance (urinary output; total fluid loss including urine and hemorrhage; total fluid infusion including HSL and 6% HES, blood product and other fluids).
Safety
Time frame: Assessed from baseline till upto end of surgery(mean duration of surgery was 372.47 ± 122.82 min in HSLgroup vs 380.61 ± 82.08 min in HES group
Assess safety of HSL in intra CABG patients: 1. Lab parameters: Hb, HCT, Na,K, Cl, Mg, lactate, glucose, and arterial blood gas. 2. Adverse events
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 1 Aug 2012.
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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.
Cindy E Boom, PhD, MD principal investigator
National Cardiovascular Center Harapan Kita, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hypertonic sodium lactate and 6% Hydroxy Ethyl Starch in people with Coronary Heart Disease, 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 1 Aug 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Efficacy (time frame: Assessed from baseline till upto end of surgery(mean duration of surgery was 372.47 ± 122.82 min in HSLgroup vs 380.61 ± 82.08 min in HES group). The study lists 2 primary outcomes in all. 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 1 Aug 2012.