Thiamine Influenced on Substrate Energy Effectiveness in Indonesian Children Undergoing Cardiopulmonary Bypass

NCT04453761 | Unknown Phase 4 DMC

• 1 other identifier: LB.02.01/VII/225/KEP.066/2017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, controlled trial design. It was conducted with a main purpose of evaluating the effect of thiamine supplementation on serum lactate and lactate-pyruvate ratio after surgery as direct indicators of tissue perfusion and indirect markers of energy substrate availability for effective mitochondrial function and intubation time as clinical outcome.

Conditions

Thiamine Deficiency; Congenital Heart Disease; Cardiopulmonary Bypass

Keywords

thiamine supplementation; congenital heart disease; paediatric cardiac surgery; cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• Evaluate the effect of thiamine supplementation to pyruvate levels

  Comparing the lab parameter indicate pyruvate levels

  at 6 hours post cross clamp removal

Secondary Outcomes (1)

• Evaluate the effect of thiamine supplementation to cardiac output.

  Within 1 days of surgery

Study Arms (2)

Drugs Group

EXPERIMENTAL

Thiamine IV

Drug: Neurobion

Placebo

PLACEBO COMPARATOR

NaCl IV

Drug: Placebo

Interventions

Neurobion DRUG

Intravenous Thiamine 2 mg/kg in Neurobion injection

Also known as: Vitamin B1 IV

Drugs Group

Placebo DRUG

Intravenous NaCl0.9%

Also known as: NaCl 0.9%

Placebo

Eligibility Criteria

• Age: 1 Month - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All patients with congenital heart disease, 2 years old or less, with moderate to severe malnutrition are included. Types of congenital heart disease suffered required subject to undergo surgery using cardiopulmonary bypass machine with Aristotle score of 6-9.

You may not qualify if:

• Body weight of less than 2 kg at the study period
• Suffering from pre-surgical tachyarrhythmia or other types of arrhythmias
• Pre-surgical sepsis
• Serum creatinine of more than 2 mg/dL
• Diagnosed with thyroid abnormalities prior to the surgery

Sponsors & Collaborators

• National Cardiovascular Center Harapan Kita Hospital Indonesia: lead

Study Sites (1)

National Cardiovascular Center Harapan Kita

Jakarta, DKI Jakarta, 11420, Indonesia

Location

Related Publications (3)

• Marwali EM, Boom CE, Budiwardhana N, Fakhri D, Roebiono PS, Santoso A, Sastroasmoro S, Slee A, Portman MA. Oral Triiodothyronine for Infants and Children Undergoing Cardiopulmonary Bypass. Ann Thorac Surg. 2017 Aug;104(2):688-695. doi: 10.1016/j.athoracsur.2017.01.001. Epub 2017 Feb 6.

  PMID: 28185643 RESULT

• Marwali EM, Boom CE, Sakidjan I, Santoso A, Fakhri D, Kartini A, Kekalih A, Schwartz SM, Haas NA. Oral triiodothyronine normalizes triiodothyronine levels after surgery for pediatric congenital heart disease*. Pediatr Crit Care Med. 2013 Sep;14(7):701-8. doi: 10.1097/PCC.0b013e3182917f87.

  PMID: 23842591 RESULT

• Luger M, Hiesmayr M, Koppel P, Sima B, Ranz I, Weiss C, Konig J, Luger E, Kruschitz R, Ludvik B, Schindler K. Influence of intravenous thiamine supplementation on blood lactate concentration prior to cardiac surgery: A double-blinded, randomised controlled pilot study. Eur J Anaesthesiol. 2015 Aug;32(8):543-8. doi: 10.1097/EJA.0000000000000205.

  PMID: 26066773 RESULT

MeSH Terms

Conditions

Thiamine Deficiency; Heart Defects, Congenital

Interventions

Vitamin B Complex; Sodium Chloride

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Eva M Marwali, MD, PhD

  National Cardiovascular Centre Harapan Kita Jakarta Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eva M Marwali, MD, Phd

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: July 1, 2020
• Study Start: July 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)