Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Cardiopulmonary Resuscitation (Thyro-CPR)

August 13, 2021 updated by: PD Dr. Johannes W. Dietrich, MD, Ruhr University of Bochum

Time-limited adaptive responses of thyroid function are common in the critically ill. About 70% of all patients treated on intensive care units develop a so-called non-thyroidal illness syndrome (NTIS) or TACITUS (thyroid allostasis in critical illness, tumours, uraemia and starvation), which is marked by low serum concentrations of the thyroid hormone T3 and other adaptive reactions of thyroid homeostasis. Occasionally, temporarily elevated concentrations of thyrotropin (TSH) and peripheral thyroid hormones are to be observed, especially after cardiopulmonary resuscitation (CPR). However, the available evidence is limited, although abnormal concentrations of thyroid hormones after CPR have occasionally been reported.

Aim of the planned study is to investigate the thyrotropic (i.e. thyroid-controlling) partial function of the anterior pituitary lobe immediately after CPR. It is intended to evaluate statistical measures of TSH concentration and peripheral thyroid hormones in de-identified datasets (protocol A). Additionally, a prospective sub-study (protocol B) aims at a more precise description of pituitary and thyroid responses by means of serial investigations in routine serum samples, both immediately after CPR and during the course of ongoing treatment. This includes the evaluation of additional possible predictors, too.

Primary endpoint of the study is changed TSH concentration immediately after CPR compared to the TSH value 24 hours later. Secondary endpoint is the relation between thyroid-controlling pituitary function and mortality.

A high proportion of patients undergoing CPR will eventually receive iodinated radiocontrast media (e.g. for computed tomography or coronary angiography). This is one of the reasons why early identifying subjects at high risk for possible iodine-induced thyrotoxicosis is important. Increased oxygen consumption of the heart in hyperthyroidism is one of the reasons for high mortality in thyrotoxicosis. Therefore, accurate diagnosis of alterations in the hypothalamus-pituitary-thyroid (HPT) axis is of paramount importance.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Transient allostatic responses of thyroid function are common in the critically ill. About 70% of all patients treated on intensive care units develop a so-called non-thyroidal illness syndrome (NTIS) or TACITUS (thyroid allostasis in critical illness, tumours, uraemia and starvation), which is marked by low serum concentrations of the thyroid hormone T3 and other adaptive reactions of thyroid homeostasis. Occasionally, temporarily elevated concentrations of thyrotropin (TSH) and peripheral thyroid hormones are to be observed, especially after cardio-pulmonary resuscitation (CPR). However, the available evidence is limited, although abnormal concentrations of thyroid hormones after CPR have been reported.

Aim of the planned study is to investigate the thyrotropic partial function of the anterior pituitary lobe immediately after CPR. It is intended to evaluate statistical moments of TSH concentration and peripheral thyroid hormones in de-identified datasets (protocol A). Additionally, a prospective substudy (protocol B) aims at a more precise description of pituitary and thyroid responses by means of serial investigations in routine serum samples, both immediately after CPR and during the course of ongoing in-patient treatment. This also includes the evaluation of additional possible predictors.

Primary endpoint of the study are changed TSH concentrations immediately after CPR compared to the value 24 hours later. Secondary endpoint is the relation between thyrotropic pituitary function and mortality.

A high proportion of patients undergoing CPR will eventually receive iodinated radiocontrast media (e.g. for computed tomography or coronary angiography). This is one of the reasons why early identifying subjects at high risk for possible iodine-induced thyrotoxicosis is important. Increases oxygen consumption of myocardial tissue in hyperthyroidism is one of the reasons for high mortality in thyrotoxicosis. Therefore, accurate diagnosis of alterations in the hypothalamus-pituitary-thyroid (HPT) axis is of paramount importance.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • NRW
      • Bochum, NRW, Germany, D-44789
        • Recruiting
        • Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Roland Köditz, M.D.
        • Sub-Investigator:
          • Nikolaos Rigas, M.D.
        • Sub-Investigator:
          • Assem Aweimer
        • Sub-Investigator:
          • Jennifer N Siekira
        • Sub-Investigator:
          • Viktoria Stab, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

De-identified datasets (protocol A) or patients (protocol B) admitted to an intensive care unit after cardiopulmonary resuscitation (CPR)

Description

Inclusion Criteria:

  • Admission after cardiopulmonary resuscitation
  • Minimum age of 18 years
  • Results of TSH and peripheral thyroid hormone concentrations already available or possibility to reorder these investigations in a post-hoc manner if consent has been obtained (i. e. time interval after venipuncture within the storage period of the central laboratory)
  • Inclusion after own consent of the patient after reawakening, via custodian or independent consultant.

Exclusion Criteria:

  • Missing data on thyroid homeostasis in the first blood specimen (obtained before 3 hours after admission)
  • Traumatic brain injury
  • Persistent hints for thyroid dysfunction, not explained by non-thyroidal illness syndrome (NTIS) / euthyroid sick syndrome (ESS) / thyroid allostasis in critical illness, tumors, uremia and starvation (TACITUS) in consecutive investigations over several days after resuscitation
  • Functionally relevant thyroid or pituitary disorder, as documented in international classification of diseases (ICD) codes.
  • Exposure to radiocontrast agents less than 3 months ago
  • Therapy with amiodarone (currently or during the previous 3 years)
  • Pregnancy
  • Known thyroid disease
  • Consent not obtained within the routine storage period of the central laboratory
  • Post-hoc-exclusion if evidence for true dysfunction the the pituitary or the thyroid became available during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Status post resuscitation
Patients or dataset that underwent resuscitation
Diagnostic test: TSH determination
Determination of serum concentration of thyrotropin (TSH)
Other Names:
  • serum thyrotropin determination
Diagnostic test: FT4 determination
Determination of serum free thyroxine (FT4) concentration
Other Names:
  • serum free T4 determination
Diagnostic test: FT3 determination
Determination of serum free triiodothyronine (FT3) concentration
Other Names:
  • serum free T3 determination
Diagnostic test: SPINA-GT
Calculation of thyroid's secretory capacity (SPINA-GT)
Other Names:
  • GT
  • Thyroid's secretory capacity
  • LOINC 82368-2
  • thyroid's incretory capacity
Diagnostic test: SPINA-GD
Calculation of total deiodinase activity (SPINA-GD)
Other Names:
  • GD
  • Sum activity of peripheral deiodinases
  • LOINC 82367-4
  • deiodination capacity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TSH response
Time Frame: three hours
Changes in TSH concentration after CPR compared to the value after 24 hours
three hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognosis
Time Frame: Through study completion, an average of 1 year
Mortality dependent on pituitary thyrotropic partial function
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-6678-BR
  • U1111-1251-7468 (Other Identifier: WHO Universal Trial Number (UTN))
  • DRKS00021695 (Registry Identifier: Deutsches Register Klinischer Studien / German Clinical Trials Register (DRKS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Sharing may be considered upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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