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Cardiac Surgery Intensive Care TreatmentPhase 3L-ThyroxineNCT06660823

Role of Levothyroxine Supplementation in Delayed Recovery Following Cardiac Surgery

A Phase 3 study testing L-thyroxine in people with Cardiac Surgery Intensive Care Treatment and Delayed Recovery From Anaesthesia, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Research indicates that hypothyroidism decreases heart contractility, reduces stroke volume and rate, affects the vascular endothelium, and increases the risk of atherosclerosis, systemic vascular resistance, hypertension, atherogenic lipid profile, and coagulation abnormality . Read more about this study

Who is it for?
Ages 45 to 70 years
What is being tested?
L-thyroxine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteEgypt
Study dates
30 Nov 2024to 25 Jun 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • Age group: Adult patients from age of 45 to70 years. (Majority of our patients falls in this age group 45-70 years, below these patients are relatively young and usually do not show delayed recovery or prolonged ventilation, while above 70 years are considered frail and more vulnerable to anesthetic medications, so we preferred to exclude them)
  • Sex: Both sexes
  • Elective, urgent and emergency open heart surgeries. (Most of urgent and emergency cases are either mechanical valve thrombosis or aortic dissection patients, and are more prone to prolonged mechanical ventilation and delayed recovery compared to elective patients)

Who cannot join

  • • Patients refuse to give informed consent.
  • Patient younger than 45 years old, older than 70 years old.
  • Off pump patients.
  • Patients known hypothyroidism on levothyroxine supplementation.
  • Patients known hyperthyroidism on Carbimazole.
  • Those developing any form of arrhythmia L-Thyroxine will be stopped immediately and the patient will be excluded from the study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Medicine ,Ain Shams University

    Cairo

Other trials in Egypt

About this study

Research indicates that hypothyroidism decreases heart contractility, reduces stroke volume and rate, affects the vascular endothelium, and increases the risk of atherosclerosis, systemic vascular resistance, hypertension, atherogenic lipid profile, and coagulation abnormality .

Hypothyroidism was reported to be strongly related to cardiovascular disease, respiratory complications, neurological complications, and a significant difference in ventilator weaning time.

Read more

Once subclinical hypothyroidism patients are treated with levothyroxine, their physical fitness measured by a 6-minute walk is significantly improved, also showed that levothyroxine treatment can optimize the treatment of heart failure with preserved functions (HFpEF) and heart failure with reduced functions (HFrEF) patients with systolic left ventricular dysfunction and sub clinical hypothyroidism (SCH).

The primary aim of this study is to investigate the effect of supplementation of oral levothyroxine in delayed recovery patients post cardiac surgery.

Read the detailed description

Research indicates that hypothyroidism decreases heart contractility, reduces stroke volume and rate, affects the vascular endothelium, and increases the risk of atherosclerosis, systemic vascular resistance, hypertension , atherogenic lipid profile, and coagulation abnormality .

Hypothyroidism was reported to be strongly related to cardiovascular disease, respiratory complications, neurological complications, and a significant difference in ventilator weaning time. Severe thyroid dysfunction is related to muscle relaxation and lead to respiratory muscle depression and disturbed conscious level.Surgical stress of cardiac surgery might be followed by a prolonged recovery process and cardiac dysfunction .

The exact physiology of thyroid disease and the relationship with post cardiac surgery remain unclear. Thus far, large-scale clinical statistical analysis evidence on the complication rate and long-term mortality is lacking. Current important prognostic assessment tools such as EuroSCORE II , and Society of Thoracic Surgeons (STS) score do not include thyroid function assessment, even though it has a significant impact on the metabolic, cardiovascular, and circulation system.

Once subclinical hypothyroidism patients are treated with levothyroxine, their physical fitness measured by a 6-minute walk is significantly improved, also showed that levothyroxine treatment can optimize the treatment of heart failure with preserved functions (HFpEF) and heart failure with reduced functions (HFrEF) patients with systolic left ventricular dysfunction and sub clinical hypothyroidism (SCH).

The heart is a major target of thyroid hormones, with maintenance of euthyroid hormone balance critical for proper function. Moreover, thyroid hormones have been shown a vital role in cardiac repair after injury beyond their roles in development and metabolism homeostasis.

After cardiac surgery with cardiopulmonary bypass (CPB), however, serum thyroid hormone levels are often decreased, especially in pediatric patients. This is called as the euthyroid sick syndrome (ESS).

It is reported that after cardiac surgery with CPB, 50% to 75% of adult patients present a decreased serum level of triiodothyronine (T3) (type 1 ESS) and 100% of pediatric patients display decreased serum levels of both T3 and tetraiodothyronine (T4) (type 2 ESS).

Because ESS has been associated with increased morbidity after cardiac surgery, it is deemed that intravenous supplementation of thyroid hormones in postoperative period is benefit to infants and small children. This view is supported by the largest randomized clinical trial so far, the Triiodothyronine for Infants and Children Undergoing CPB (TRICC) study, in which subgroup analysis shows a significant reduction in mechanical ventilation time, less use of inotropic drugs, and better cardiac function with intravenous T3 supplementation after surgery in pediatric patients aged <5 months.

Ischemia and reperfusion occur during almost every cardiac surgery and myocardial ischemia/reperfusion injury (IRI) is an important cause of morbidity and mortality in the early postoperative period after cardiac surgery. It has been shown that thyroid hormones can limit myocardial IRI via a fine balance between proapoptotic and prosurvival signaling pathways.Furthermore, thyroid hormones can provide a protection against myocardial IRI by inducing pharmacological preconditioning.The available evidence also indicates that perioperative oral T3 therapy can significantly attenuate the postoperative decline in serum T3 level or maintain total and free serum T3 levels within normal limits in adult and pediatric patients undergoing cardiac surgery.Given that oral administration is a safe, convenient and feasible route of perioperative medication. This has been proven by the single-center, prospective, double blind, randomized placebo-controlled clinical pilot trial including 40 patients receiving a dose of 0.4mg/kg (trial group, thyroid tablet taken orally once a day, for 4 days before surgery).In summary, this pilot study demonstrated that children after cardiac surgery with CPB are at a high risk to develop postoperative ESS. Preoperatively short-term oral thyroid hormones can reduce severity of postoperative ESS without negative effects and provides a protection against myocardial IRI by increasing HSP70 and MHCa expression.

In another reported double blind, placebo-controlled trial in 100 infants with normal thyroid function. Subjects underwent cardiac surgery and were randomly assigned during a 16-month period into 2 groups (50 in the thyroxine supplementation group and 50 in the placebo group) to determine whether there was an association between oral thyroxine (T4) supplementation and changes in cardiac index (CI), along with other important outcomes. Subjects in the study group received an oral dose of 5 µg/kg of T4 starting 12 hours before surgery and every morning thereafter while in the intensive care unit. Subjects in the study group had higher CI than did the placebo group (CI 0.30 L/min/m2 higher; P = .04).

It has been well described that early after the initiation of CPB, particularly DHCA, thyroid-stimulating hormone concentration is raised, responding to decreased concentrations of triiodothyronine (T3), and that levels restore during a period of days, beginning with thyroid stimulating hormone and followed by T3, an entity referred as ''euthyroid sick syndrome.'' An actual etiology for these changes has not been precisely described; however, hemodilution, hypothermia, and inflammation have been implicated. As of now, thyroid hormone supplementation remains the mainstay therapy for euthyroid sick syndrome.

This study , like several others, demonstrates that perioperative thyroid hormone supplementation is associated with improved outcomes. They demonstrated that Thyroid hormone levels are reduced significantly in the immediate postoperative period after open-heart surgery. Oral T4 supplementation improves the CI and reduces the inotropic requirement. In addition, it reduces the duration of mechanical ventilation, ICU and hospital stay, and TISS in infants after surgery for complex congenital heart defects.

Routinely, patients with delayed recovery and/or prolonged mechanical ventilation are managed as follow :

  1. Full neurological examination, CT brain, repeated CT brain after 48-hour, MRI stroke protocol, adding of brain stimulants medications and if fits developed antiepileptics would be added accordingly.
  2. Liver profile checked and liver support added,
  3. Renal profile checked, stoppage of nephrotoxic drugs, fluids chart, renal dose adjustment of medications.
  4. Blood sugar hourly monitored.
  5. Sepsis surveillance by withdrawing pan cultures, replacing old IV catheters upgrading antibiotics accordingly.

This is typically included in institutional ICU protocol. The primary aim of this study is to investigate the effect of supplementation of oral levothyroxine in delayed recovery patients post cardiac surgery.

Being tested
L-thyroxine, Placebo Oral Tablet
Keywords
L-Thyroxine, Delayed recovery post cardiac surgery, hypthyroidism
Medical subject headings
Delayed Emergence from Anesthesia, Euthyroid Sick Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • L-thyroxineDrug

    Patients who show signs of delayed recovery defined as either prolonged ventilation for 48 hours or delayed conscious level recovery for 48 hours despite exclusion of muscle relaxants and/or sedative drugs. Those patients will undergo CT brain, CT chest and neurological examination to exclude structural damage as per institutional protocols. Also, metabolic profile screening including full kidney function, full liver function, electrolyte to exclude correctable metabolic abnormalities. and thyroid profile (TSH, free T3, free T4) sick euthyroid patients who are having normal FreeT3, normal Free T4, low TSH and low level of free T3 or freeT4 will be included in the study according lab reference.Daily assessment of conscious level according to Glasgow Coma Scale (GCS) and spontaneous breathing trial by ICU consultant (the investigator) till ICU discharge.

    Patients will receive levothyroxine via Ryle, dose of 25 to 50 ug/ day according to BMI.

  • Placebo Oral TabletDrug

    patients will receive placebo oral tablet

Study groups in NCT06660823
Study groupRoleWhat they receive
Group A (Study group)Active comparatorgroup A will receive levothyroxine via Ryle, dose of 25 to 50 ug/ day according to BMI
Receives: Drug: L-thyroxine
Group B (Control)Placebo comparatorgroup B will receive placebo in form of inert starch tablet
Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glasgow Coma Scale (GCS) From Intervention Initiation to ICU Discharge (Δ)

    The Glasgow Coma Scale (GCS) assesses conscious level through three components:

    Eye response (scored 1-4):

    4: Opens eyes spontaneously

    3: Opens eyes to verbal command

    2: Opens eyes to pain

    1: No eye opening

    Verbal response (scored 1-5):

    5: Oriented and converses

    4: Confused

    3: Inappropriate words

    2: Incomprehensible sounds

    1: No verbal response

    Motor response (scored 1-6):

    6: Obeys commands

    5: Localizes to pain

    4: Withdraws from pain

    3: Abnormal flexion (decorticate)

    2: Abnormal extension (decerebrate)

    1: No motor response

    The total GCS score ranges from 3 (worst) to 15 (best), with higher scores indicating better neurological function. The primary outcome is the change in total GCS score from baseline (48 hours postoperatively, before intervention) to ICU discharge.

    Measured: From intervention initiation (48 hours postoperatively) to ICU discharge, up to 1 month postoperatively. (i.e., within 28 days after baseline).

Secondary outcomes (6)
  1. Total Duration of Mechanical Ventilation

    Total time (in hours) from initiation of mechanical ventilation postoperatively until successful extubation, including time before and after study intervention.

    Measured: From surgery completion until extubation (assessed for ≤30 days postoperatively).

  2. Duration of Intensive Care Unit (ICU) Stay

    Total time (in days) from ICU admission after cardiac surgery until discharge from ICU or death.

    Measured: From ICU admission until discharge/death (assessed for ≤30 days postoperatively).

  3. Total Hospital Stay Stay.

    The total hospital stay will be recorded in days and compared between both groups.

    Measured: 30 days

  4. Average Inotropic Support Infusion Rate in ICU

    Average infusion rate (in ng/kg/min) of norepinephrine and epinephrine administered during ICU stay. Calculated as total dose (ng) divided by patient weight (kg) and total infusion duration (minutes). Does not include intraoperative inotropic support.

    Measured: From ICU admission until discontinuation of inotropic support or ICU discharge (assessed daily for ≤30 days).

  5. Change in Left Ventricular Ejection Fraction (LVEF) From Baseline to ICU Discharge

    Absolute change in left ventricular ejection fraction (LVEF) measured by transthoracic echocardiography, calculated as:

    Δ EF = Postoperative EF

    • Preoperative EF Δ EF
    • Postoperative EF-Preoperative EF Negative values indicate decline in cardiac function.

    Measured: Preoperative assessment: Within 24 hours before surgery Postoperative assessment: At ICU discharge (≤30 days postoperatively)

  6. Number of Participants With New-onset Supraventricular Arrhythmia

    Incidence of new-onset supraventricular arrhythmias (atrial fibrillation, atrial flutter, or supraventricular tachycardia) confirmed by 12-lead ECG during ICU stay. Excludes pre-existing arrhythmias.

    Measured: From ICU admission until discharge or death (≤30 days postoperatively).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2024
  2. Study start30 Nov 2024
  3. Primary completion15 Jun 2025
  4. Study completion25 Jun 2025

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a prospective, randomized controlled trial that will study the postoperative clinical outcomes of levothyroxine supplementation in delayed recovery or prolonged ventilation patients post cardiac surgery. Randomization will be performed using a computer-generated randomization sequence and allocation concealment to be maintained all through the time of procedure, by using opaque, numbered, and sealed envelopes. Patients will be randomly allocated by computer generated randomization into two groups A and B: * Group A (Study group): patients receiving oral supplementation of levothyroxine. * Group B (Control): patients receiving Placebo drug.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06660823
Sponsor's protocol ID
FMASU R237/2024
Acronym
L-Thyroxine
Status last verified
Aug 2025
First submitted
24 Oct 2024
Last updated
17 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Duntas LH, Jonklaas J. Levothyroxine Dose Adjustment to Optimise Therapy Throughout a Patient's Lifetime. Adv Ther. 2019 Sep;36(Suppl 2):30-46. doi: 10.1007/s12325-019-01078-2. Epub 2019 Sep 4.

    PubMed 31485977
  • Flores S, Checchia PA. Inflammatory and neurohormonal modulation for congenital heart surgery: The quest continues. J Thorac Cardiovasc Surg. 2018 Sep;156(3):1207-1208. doi: 10.1016/j.jtcvs.2018.06.004. Epub 2018 Jun 22. No abstract available.

    PubMed 30005886
  • Batra YK, Singh B, Chavan S, Chari P, Dhaliwal RS, Ramprabu K. Effects of cardiopulmonary bypass on thyroid function. Ann Card Anaesth. 2000 Jul;3(2):3-6.

    PubMed 17848764
  • Zhang JQ, Yang QY, Xue FS, Zhang W, Yang GZ, Liao X, Meng FM. Preoperative oral thyroid hormones to prevent euthyroid sick syndrome and attenuate myocardial ischemia-reperfusion injury after cardiac surgery with cardiopulmonary bypass in children: A randomized, double-blind, placebo-controlled trial. Medicine (Baltimore). 2018 Sep;97(36):e12100. doi: 10.1097/MD.0000000000012100.

    PubMed 30200092
  • Kumar A, Taliyan R, Sharma PL. Evaluation of thyroid hormone induced pharmacological preconditioning on cardiomyocyte protection against ischemic-reperfusion injury. Indian J Pharmacol. 2012 Jan;44(1):68-72. doi: 10.4103/0253-7613.91870.

    PubMed 22345873
  • Plumpton K, Haas NA. Identifying infants at risk of marked thyroid suppression post-cardiopulmonary bypass. Intensive Care Med. 2005 Apr;31(4):581-7. doi: 10.1007/s00134-004-2549-1. Epub 2005 Jan 28.

    PubMed 15678312
  • Gerdes AM, Ojamaa K. Thyroid Hormone and Cardioprotection. Compr Physiol. 2016 Jun 13;6(3):1199-219. doi: 10.1002/cphy.c150012.

    PubMed 27347890
  • Biondi B, Klein I. Hypothyroidism as a risk factor for cardiovascular disease. Endocrine. 2004 Jun;24(1):1-13. doi: 10.1385/ENDO:24:1:001.

    PubMed 15249698

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing L-thyroxine in people with Cardiac Surgery Intensive Care Treatment and Delayed Recovery From Anaesthesia, run by Ain Shams University at 1 site in Egypt.

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 3 inclusion and 6 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 17 Aug 2025. 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 Egypt. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Glasgow Coma Scale (GCS) From Intervention Initiation to ICU Discharge (Δ) (time frame: From intervention initiation (48 hours postoperatively) to ICU discharge, up to 1 month postoperatively. (i.e., within 28 days after baseline).). 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 NCT06660823, which also lists 8 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 17 Aug 2025.

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