Thyroid Function in Critically Ill Patients With Acute Kidney Injury

Secondary Hypothyroidism Clinical Trial

Official title:

Association of Continuous Veno-venous Hemodiafiltration With Citrate Anticoagulation to Thyroid Function in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04767763
• Other study ID #: 02-0064/07/287
• Status: Completed
• Start date: February 19, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2021
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Hypothyroidism
• Secondary Hypothyroidism

Intervention

Diagnostic Test:
• Assessment of TSH, fT3, fT4,TRH, TT3, TT4, rT3 in patients with CVVHDF
blood samples were collected before initiation of CRRT and at 1,2,3,6,9-day following. Last samples were collected 3 days after the end of CRRT.

Locations

Country	Name	City	State
Poland	Medical University of Gdansk - Departament of Anesthesiology and Intensive Care	Gdansk	Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood concentrations of thyroid hormones	TSH, fT3, fT4, TRH, TT3, TT4, rT3	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.