Evaluation of the Efficacy and Safety of Levothyroxine in Brain Death Organ Donors: a Randomized Controled Trial

NCT02211053 | Terminated Phase 4

• 1 other identifier: 2014-987
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the feasibility of a randomized controlled trial comparing levothyroxine to placebo in neurologically deceased donors

Conditions

Brain Dead Organ Donors

Keywords

Organ donation; Brain dead; Levothyroxine

Outcome Measures

Primary Outcomes (2)

• Study feasibility

  1\) proportion of eligible recruited patients 2)proportion of recruited patients who completed the study 3) proportion of protocol violation

  In 2 years

• Variation in left ventricular ejection fraction

  6 hours post infusion

Secondary Outcomes (3)

• Numbers of donated hearts

  On organ donation surgery

• Incidence of de novo atrial fibrillation

  From beginning of infusion until beginning of retrieval surgery

• Time from recruitment to the administration of the study drug

  From randomization to 12 hours post randomization

Study Arms (2)

Levothyroxine

ACTIVE COMPARATOR

Levothyroxine infusion 20 mg IV bolus then 10 mg/h infusion

Drug: Levothyroxine

Placebo

PLACEBO COMPARATOR

Infusion matched to intervention arm

Drug: placebo

Interventions

Levothyroxine DRUG

20 mg IV bolus + 10 mg/h infusion

Also known as: Synthroid(R)

Levothyroxine

placebo DRUG

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior signed written informed from family member (no more needed following amendment in July 2016)
• years of age or older
• Brain death diagnosis
• Left ventricular ejection fraction \< 50% determined by transthoracic echocardiography or hemodynamic instability defined as a mean dose of noradrenaline 0.1 mcg/kg/min + vasopressin

You may not qualify if:

• Heart failure history (removed after june 2015)
• Chronic exogenous oral T4 or T3 before death (removed after june 2015)
• Having received T4 infusion before recruitment(removed after june 2015)
• Echographic images not interpretable
• Age 75 and older(removed after june 2015)
• Prior coronary heart disease defined as prior coronary artery bypass graft or percutaneous coronary intervention (with or without stents)(removed after june 2015)

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead

Study Sites (1)

Hopital du Sacré-Coeur de Montreal

Montreal, Quebec, H4J1C5, Canada

Location

Related Publications (1)

• Frenette AJ, Williamson D, Williams V, Lagace AM, Charbonney E, Serri K. A Pilot Randomized Controlled Trial Comparing Levothyroxine to Placebo in Neurologically Deceased Donors. Prog Transplant. 2019 Sep;29(3):261-268. doi: 10.1177/1526924819855083. Epub 2019 Jun 9.

  PMID: 31179831 DERIVED

MeSH Terms

Conditions

Brain Death

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Anne Julie Frenette, M.Sc

  Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intensive Care Pharmacist, Associate Clinical Professor

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 7, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

CA (1)