Myocardial InjuryNCT04051580
Comparison of Lactated Ringer's Solution and PlasmaLyte-A as a Base Solution for Del Nido Cardioplegia
A study testing Lactated Ringer in people with Myocardial Injury, run by Mahidol University at 1 site in Thailand.
Trial summary
Del Nido cardioplegia has been used exclusively for myocardial protection in pediatrics cardiac surgery for decades. Its unique properties including lidocaine which helps counteract potassium depolarization of the myocardial cell membrane, inhibition of intracellular calcium accumulation, preservation of intracellular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Injury
- What is being tested?
- Lactated Ringer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- 5 Aug 2019to 31 Dec 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 18 years or older undergoing elective adult cardiac surgery
Who cannot join
- Emergency surgery
- Patient who does not want to participate in the study
- Lidocaine allergy
Trial locations and contacts
1 site in 1 country.
About this study
Del Nido cardioplegia has been used exclusively for myocardial protection in pediatrics cardiac surgery for decades. Its unique properties including lidocaine which helps counteract potassium depolarization of the myocardial cell membrane, inhibition of intracellular calcium accumulation, preservation of intracellular high-energy phosphates, free-radical scavenging and acid-base buffering have been proven to be very effective for myocardial protection during cardiac surgery for congenital heart disease and acquired heart disease. Recent studies have proven its safety, efficacy, and cost-effectiveness for myocardial protection in adult cardiac surgery as a single dose cardioplegia which is typically administered in a single dose fashion or with extended dosing intervals. In contrast, Traditional blood cardioplegia is commonly administered approximately every 20 minutes. These characteristics of del Nido cardioplegia allow for fewer interruptions and improve surgical workflow. The base solution for del Nido cardioplegia is normally Plasma-Lyte A (Baxter Healthcare Corporation, Deerfield, IL, USA) which has an electrolyte composition similar to the extracellular fluid and is calcium-free. Unfortunately, an unavailability of PlasmaLyte-A in many countries precluding utilization of del Nido cardioplegia with its normal base solution in many cardiac centers. To access the benefits of del Nido cardioplegia, we utilize lactated Ringer's solution as the base solution. This prospective randomized study aimed to evaluate myocardial preservation and clinical outcomes when using lactated Ringer's solution compared with PlasmaLyte-A as a base solution for del Nido cardioplegia.
Read the detailed description
This clinical trial is performed at Ramathibodi hospital, Mahidol university in Bangkok, Thailand. The protocol has been approved by institutional ethical committee (ref. ID 03-61-43) with informed consent required for all patients.
The difference of 24 hour post-op troponin level between the del Nido cardioplegia and the blood cardioplegia group from previous randomized study were 2.3 (SD 2.1) and 7.0 (SD 14.7) ng/mL, respectively (p = 0.053). Our previous observational study also exhibited comparable results between modified del Nido cardioplegia and blood cardioplegia. The author estimated the sample size of 160 randomized patients to give 80% power at the 5% significant level (alpha 0.05, beta 0.2). Giving allowance for attrition, a sample size of 100 was chosen in each group.
Patients aged 18 years or older undergoing elective cardiac surgery for acquired heart disease (including isolated coronary artery bypass grafting(CABG), isolated valve surgery, combined valve surgery, or concomitant CABG and valve surgery) are randomized 1:1 into lactated Ringer's solution (study group) and PlasmaLyte-A (control group).
For patients randomized to lactated Ringer's solution (study group), lactated Ringer's solution is used as a base solution for del Nido cardioplegia.
For patients randomized to PlasmaLyte-A (control group), PlasmaLyte-A (Baxter Healthcare Corporation, Deerfield, IL, USA) is used as a base solution for del Nido cardioplegia.
Del Nido cardioplegia is delivered 1:4 with 1 part of oxygenated pump blood to 4 parts of cardioplegia solution. Del Nido cardioplegia can be delivered antegrade through aortic root catheter, directly through the coronary ostia or retrograde via the coronary sinus depending on the type of operation and degree of aortic valve insufficiency. Our protocol is to administer a single dose 20 mL/kg with maximum dose of 1000 mL for patients larger than 50 kg. After 90 minutes of aortic cross clamp time, the surgeon decides how much subsequent doses needs to be administered. If coronary bypass grafting is required, 5-10 mL of del Nido cardioplegia is administered via the saphenous vein graft or the radial artery graft to test the distal anastomosis. In our circuit, del Nido cardioplegia passes through a non-recirculating cardioplegia set with a coil heat exchanger and a delivery temperature of 4°C. It is generally administered over 1-2 minutes with system pressure 100-200 mmHg.
Primary outcomes comprised assessments of myocardial injury, including troponin-T level at immediate post-op, 12 hour post-op, and 24 hour post-op.
Secondary outcomes comprised assessments of additional measures of myocardial protection (including incidence of ventricular fibrillation after aortic cross-clamp removal; post-op left ventricular ejection fraction (LVEF) change; duration of inotrope/vasopressor requirement; and requirement for intra-aortic balloon pump (IABP) support), intraoperative outcomes (including total volume of cardioplegia; number of doses; total cardiopulmonary bypass (CPB) time; and aortic cross-clamp time), and clinical outcomes (including intensive care unit ICU) stay; hospital stay; incidence of postoperative atrial fibrillation or flutter; mortality; postoperative complications; and red cell transfusion).
Patient characteristics and postoperative outcomes were as defined by the Society of Thoracic Surgeons (STS) Adult Cardiac Surgical Database. LVEF was assessed by transesophageal echocardiography before surgery and at the end of operation.
- Conditions
- Myocardial Injury
- Being tested
- Lactated Ringer
- Keywords
- myocardial protection, cardiac surgery, del Nido cardioplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated RingerDrug
Also called PlasmaLyte-A
Comparison of Lactated Ringer's Solution and PlasmaLyte-A as a Base Solution for Del Nido Cardioplegia
| Study group | Role | What they receive |
|---|---|---|
| Lactated Ringer's solution | Experimental | For patients randomized to lactated Ringer's solution (study group), lactated Ringer's solution is used as a base solution for del Nido cardioplegia. Receives: Drug: Lactated Ringer |
| PlasmaLyte-A | Active comparator | For patients randomized to PlasmaLyte-A (control group), PlasmaLyte-A (Baxter Healthcare Corporation, Deerfield, IL, USA) is used as a base solution for del Nido cardioplegia. Receives: Drug: Lactated Ringer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial injury
troponin-T level at 24 hour post-op
Measured: 24 hour post-op
Secondary outcomes (11)
Incidence of ventricular fibrillation after aortic cross-clamp removal
Ventricular fibrillation after aortic cross-clamp removal required defibrillation
Measured: Intra-operative period
Post-op left ventricular ejection fraction (LVEF) change
Difference between pre-op and post-op LVEF. LVEF was assessed by transesophageal echocardiography before surgery and at the end of operation.
Measured: Intra-operative period
Duration of inotrope/vasopressor requirement
Length of inotropic or vasopressor support in intensive care unit (hour)
Measured: up to 1 hour (During admission in intensive care unit)
Incidence of intra-aortic balloon pump (IABP) insertion
Requirement for intra-aortic balloon pump (IABP) support
Measured: up to 1 hour (During admission in intensive care unit)
Incidence of Operative mortality
Operative mortality includes both (1) all deaths occurring during the hospitalization in which the operation was performed, even if after 30 days; and (2) those deaths occurring after discharge from the hospital, but within 30 days of the procedure.
Measured: up to 1 month postoperatively
Incidence of Permanent Stroke
Postoperative stroke (i.e., any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain that did not resolve within 24 hours.
Measured: up to 1 month postoperatively
Incidence of Renal Failure
Acute or worsening renal failure resulting in one or more of the following:1.Increase of serum creatinine to ≥ 4.0 with an increase of at least 0.5mg/dl or 3x most recent preoperative creatinine level.2.A new requirement for dialysis postoperatively.
Measured: up to 1 month postoperatively
Incidence of Prolonged Ventilation > 24 hours
Prolonged post-operative pulmonary ventilation > 24.0 hours. The hours of postoperative ventilation time include OR exit until extubation, plus any additional hours following reintubation.
Measured: up to 1 month postoperatively
Incidence of Deep sternal wound infection
Deep sternal wound infection or mediastinitis (according to CDC definition) diagnosed within 30 days of the operation or any time during the hospitalization for the surgery
Measured: up to 1 month postoperatively
Incidence of Reoperation for any reason
Reoperation for bleeding/tamponade, valvular dysfunction, graft occlusion, other cardiac reason, or non-cardiac reason
Measured: up to 1 month postoperatively
Incidence of Major Morbidity or Operative Mortality
A composite endpoint defined as any of the outcomes listed above, including; Operative mortality, Permanent Stroke,Renal Failure, Prolonged Ventilation > 24 hours, Deep sternal wound infection, Reoperation for any reason.
Measured: up to 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start5 Aug 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Narongrit Kantathut, MD, Principal investigator, Ramathibodi hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051580
- Sponsor's protocol ID
- 036143
- Status last verified
- Mar 2024
- First submitted
- 8 Aug 2019
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ad N, Holmes SD, Massimiano PS, Rongione AJ, Fornaresio LM, Fitzgerald D. The use of del Nido cardioplegia in adult cardiac surgery: A prospective randomized trial. J Thorac Cardiovasc Surg. 2018 Mar;155(3):1011-1018. doi: 10.1016/j.jtcvs.2017.09.146. Epub 2017 Nov 13.
PubMed 29246552Kantathut N, Krathong P, Khajarern S, Leelayana P, Cherntanomwong P. Comparison of lactated Ringer's solution and Plasma-Lyte A as a base solution for del Nido cardioplegia: a prospective randomized trial. Eur J Cardiothorac Surg. 2024 Mar 1;65(3):ezae018. doi: 10.1093/ejcts/ezae018.
PubMed 38244592
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lactated Ringer's Solution and PlasmaLyte-A as a Base Solution for Del Nido Cardioplegia
- ClinicalTrials.gov ID
- NCT04051580
- Acronym / sponsor ID
- 036143
- Conditions
- Myocardial Injury
- Keywords
- myocardial protection, cardiac surgery, del Nido cardioplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Aug 2019 (actual)
- 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.
Del Nido cardioplegia has been used exclusively for myocardial protection in pediatrics cardiac surgery for decades. Its unique properties including lidocaine which helps counteract potassium depolarization of the myocardial cell membrane, inhibition of intracellular calcium accumulation, preservation of intracellular high-energy phosphates, free-radical scavenging and acid-base buffering have been proven to be very effective for myocardial protection during cardiac surgery for congenital heart disease and acquired heart disease. Recent studies have proven its safety, efficacy, and cost-effectiveness for myocardial protection in adult cardiac surgery as a single dose cardioplegia which is typically administered in a single dose fashion or with extended dosing intervals. In contrast, Traditional blood cardioplegia is commonly administered approximately every 20 minutes. These characteristics of del Nido cardioplegia allow for fewer interruptions and improve surgical workflow. The base solution for del Nido cardioplegia is normally Plasma-Lyte A (Baxter Healthcare Corporation, Deerfield, IL, USA) which has an electrolyte composition similar to the extracellular fluid and is calcium-free. Unfortunately, an unavailability of PlasmaLyte-A in many countries precluding utilization of del Nido cardioplegia with its normal base solution in many cardiac centers. To access the benefits of del Nido cardioplegia, we utilize lactated Ringer's solution as the base solution. This prospective randomized study aimed to evaluate myocardial preservation and clinical outcomes when using lactated Ringer's solution compared with PlasmaLyte-A as a base solution for del Nido cardioplegia.
Detailed description
This clinical trial is performed at Ramathibodi hospital, Mahidol university in Bangkok, Thailand. The protocol has been approved by institutional ethical committee (ref. ID 03-61-43) with informed consent required for all patients.
The difference of 24 hour post-op troponin level between the del Nido cardioplegia and the blood cardioplegia group from previous randomized study were 2.3 (SD 2.1) and 7.0 (SD 14.7) ng/mL, respectively (p = 0.053). Our previous observational study also exhibited comparable results between modified del Nido cardioplegia and blood cardioplegia. The author estimated the sample size of 160 randomized patients to give 80% power at the 5% significant level (alpha 0.05, beta 0.2). Giving allowance for attrition, a sample size of 100 was chosen in each group.
Patients aged 18 years or older undergoing elective cardiac surgery for acquired heart disease (including isolated coronary artery bypass grafting(CABG), isolated valve surgery, combined valve surgery, or concomitant CABG and valve surgery) are randomized 1:1 into lactated Ringer's solution (study group) and PlasmaLyte-A (control group).
For patients randomized to lactated Ringer's solution (study group), lactated Ringer's solution is used as a base solution for del Nido cardioplegia.
For patients randomized to PlasmaLyte-A (control group), PlasmaLyte-A (Baxter Healthcare Corporation, Deerfield, IL, USA) is used as a base solution for del Nido cardioplegia.
Del Nido cardioplegia is delivered 1:4 with 1 part of oxygenated pump blood to 4 parts of cardioplegia solution. Del Nido cardioplegia can be delivered antegrade through aortic root catheter, directly through the coronary ostia or retrograde via the coronary sinus depending on the type of operation and degree of aortic valve insufficiency. Our protocol is to administer a single dose 20 mL/kg with maximum dose of 1000 mL for patients larger than 50 kg. After 90 minutes of aortic cross clamp time, the surgeon decides how much subsequent doses needs to be administered. If coronary bypass grafting is required, 5-10 mL of del Nido cardioplegia is administered via the saphenous vein graft or the radial artery graft to test the distal anastomosis. In our circuit, del Nido cardioplegia passes through a non-recirculating cardioplegia set with a coil heat exchanger and a delivery temperature of 4°C. It is generally administered over 1-2 minutes with system pressure 100-200 mmHg.
Primary outcomes comprised assessments of myocardial injury, including troponin-T level at immediate post-op, 12 hour post-op, and 24 hour post-op.
Secondary outcomes comprised assessments of additional measures of myocardial protection (including incidence of ventricular fibrillation after aortic cross-clamp removal; post-op left ventricular ejection fraction (LVEF) change; duration of inotrope/vasopressor requirement; and requirement for intra-aortic balloon pump (IABP) support), intraoperative outcomes (including total volume of cardioplegia; number of doses; total cardiopulmonary bypass (CPB) time; and aortic cross-clamp time), and clinical outcomes (including intensive care unit ICU) stay; hospital stay; incidence of postoperative atrial fibrillation or flutter; mortality; postoperative complications; and red cell transfusion).
Patient characteristics and postoperative outcomes were as defined by the Society of Thoracic Surgeons (STS) Adult Cardiac Surgical Database. LVEF was assessed by transesophageal echocardiography before surgery and at the end of operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactated Ringer's solution | Experimental | Drug: Lactated RingerFor patients randomized to lactated Ringer's solution (study group), lactated Ringer's solution is used as a base solution for del Nido cardioplegia. |
| PlasmaLyte-A | Active comparator | Drug: Lactated RingerFor patients randomized to PlasmaLyte-A (control group), PlasmaLyte-A (Baxter Healthcare Corporation, Deerfield, IL, USA) is used as a base solution for del Nido cardioplegia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients age 18 years or older undergoing elective adult cardiac surgery
Key exclusion criteria (3 listed)
- Emergency surgery
- Patient who does not want to participate in the study
- Lidocaine allergy
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 |
|---|---|---|
| Lactated RingerAlso: PlasmaLyte-AComparison of Lactated Ringer's Solution and PlasmaLyte-A as a Base Solution for Del Nido Cardioplegia | Drug | Lactated Ringer's solution, PlasmaLyte-A |
Primary outcome
Myocardial injury
Time frame: 24 hour post-op
troponin-T level at 24 hour post-op
11 secondary outcomes
Incidence of ventricular fibrillation after aortic cross-clamp removal
Time frame: Intra-operative period
Post-op left ventricular ejection fraction (LVEF) change
Time frame: Intra-operative period
Duration of inotrope/vasopressor requirement
Time frame: up to 1 hour (During admission in intensive care unit)
Incidence of intra-aortic balloon pump (IABP) insertion
Time frame: up to 1 hour (During admission in intensive care unit)
Incidence of Operative mortality
Time frame: up to 1 month postoperatively
Incidence of Permanent Stroke
Time frame: up to 1 month postoperatively
Incidence of Renal Failure
Time frame: up to 1 month postoperatively
Incidence of Prolonged Ventilation > 24 hours
Time frame: up to 1 month postoperatively
Incidence of Deep sternal wound infection
Time frame: up to 1 month postoperatively
Incidence of Reoperation for any reason
Time frame: up to 1 month postoperatively
Incidence of Major Morbidity or Operative Mortality
Time frame: up to 1 month postoperatively
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 15 Mar 2024.
- Background: PubMed 29246552Ad N, Holmes SD, Massimiano PS, Rongione AJ, Fornaresio LM, Fitzgerald D. The use of del Nido cardioplegia in adult cardiac surgery: A prospective randomized trial. J Thorac Cardiovasc Surg. 2018 Mar;155(3):1011-1018. doi: 10.1016/j.jtcvs.2017.09.146. Epub 2017 Nov 13.
- Results publication: PubMed 38244592Kantathut N, Krathong P, Khajarern S, Leelayana P, Cherntanomwong P. Comparison of lactated Ringer's solution and Plasma-Lyte A as a base solution for del Nido cardioplegia: a prospective randomized trial. Eur J Cardiothorac Surg. 2024 Mar 1;65(3):ezae018. doi: 10.1093/ejcts/ezae018.
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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.
Narongrit Kantathut, MD principal investigator
Ramathibodi hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactated Ringer in people with Myocardial Injury, run by Mahidol University at 1 site in Thailand.
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 1 inclusion and 3 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 15 Mar 2024. 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 Thailand. 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.
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?
Myocardial injury (time frame: 24 hour post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04051580, which also lists 2 linked publications.
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 15 Mar 2024.