Comparison of Lactated Ringer's Solution and PlasmaLyte-A as a Base Solution for Del Nido Cardioplegia

NCT04051580 | Completed

• 1 other identifier: 036143
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Myocardial Injury

Keywords

myocardial protection; cardiac surgery; del Nido cardioplegia

Outcome Measures

Primary Outcomes (1)

• Myocardial injury

  troponin-T level at 24 hour post-op

  24 hour post-op

Secondary Outcomes (11)

• Incidence of ventricular fibrillation after aortic cross-clamp removal

  Intra-operative period

• Post-op left ventricular ejection fraction (LVEF) change

  Intra-operative period

• Duration of inotrope/vasopressor requirement

  up to 1 hour (During admission in intensive care unit)

• Incidence of intra-aortic balloon pump (IABP) insertion

  up to 1 hour (During admission in intensive care unit)

• Incidence of Operative mortality

  up to 1 month postoperatively

Study Arms (2)

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.

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.

Drug: Lactated Ringer

Interventions

Lactated Ringer DRUG

Comparison of Lactated Ringer's Solution and PlasmaLyte-A as a Base Solution for Del Nido Cardioplegia

Also known as: PlasmaLyte-A

Lactated Ringer's solution; PlasmaLyte-A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18 years or older undergoing elective adult cardiac surgery

You may not qualify if:

• Emergency surgery
• Patient who does not want to participate in the study
• Lidocaine allergy

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Related Publications (2)

• 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.

  PMID: 29246552 BACKGROUND

• Kantathut 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.

  PMID: 38244592 RESULT

MeSH Terms

Interventions

Ringer's Lactate; Plasmalyte A

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Narongrit Kantathut, MD

  Ramathibodi hospital, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 9, 2019
• Study Start: August 5, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

TH (1)