Thyroid Function in Critically Ill Patients With Acute Kidney Injury

Completed

• Conditions: Secondary Hypothyroidism
• Interventions: Diagnostic Test: Assessment of TSH, fT3, fT4,TRH, TT3, TT4, rT3 in patients with CVVHDF

• Registration Number: NCT04767763
• Lead Sponsor: Medical University of Gdansk

Brief Summary

The objective of this study was to assess the changes in thyroid hormones and its activity during CRRT in patients with Acute Kidney Injury.

Detailed Description

After approval from the local Bioethics Committee of the Medical University of Gdańsk in Poland, the study was carried out between February 2019 and February 2020 among 32 patients admitted to ICU. There was no need to obtain written consent from the patients since the study was observational with no therapeutic intervention and decisional incapacity caused either by sedative drugs or severe condition of the patient.

Patients with acute kidney injury and indications for initiation of continuous renal replacement therapy (CRRT) were included to this study irrespective of their gender, race and age. Exclusion criteria were patients with previous end-stage chronic kidney disease treated with dialysis.

After decision to implement CRRT the serial blood samples were collected into two red-top tube (no anticoagulant or preservative) before initiation of CRRT and at 1,2,3,6,9,12,15,18-day following. Last samples were collected 3 days after the end of CRRT. Level of TSH, fT3 and fT4 were checked from the first tube after collecting the blood. Second tube was kept frozen until levels of TRH, TT3, TT4, rT3 could be measured. In all the patients high-dose continuous veno-venous hemodiafiltration (CVVHDF) with citrate anticoagulation was performed. Blood flow and dialysis dosage were the same for every patient depending on their weight. The weight was rounded up or down and patients were assigned to the nearest group.

Study Timeline

• Study Start: 2019-02-19
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-22
• Last Update Submitted: 2021-02-22
• Study First Posted: 2021-02-23
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Patients with acute kidney injury and indications for initiation of continuous renal replacement therapy (CRRT)

Exclusion Criteria

Exclusion criteria were patients with previous end-stage chronic kidney disease treated with dialysis or with history of hypothyroidism.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Acute Kidney Injury	Assessment of TSH, fT3, fT4,TRH, TT3, TT4, rT3 in patients with CVVHDF	Patients with acute kidney injury and indications for initiation of continuous renal replacement therapy (CRRT) were included to this study irrespective of their gender, race and age.

Primary Outcome Measures

Name	Time	Method
blood concentrations of thyroid hormones	Samples were collected up to 1 hour before initiation and after 24, 48, 72, 144, 216 hours after initiation of CRRT. Last sample was collected 72 hours after the end of CRRT.	TSH, fT3, fT4, TRH, TT3, TT4, rT3

Trial Locations

Locations (1)

Medical University of Gdansk - Departament of Anesthesiology and Intensive Care; 🇵🇱 Gdańsk, Pomorskie, Poland