Clinical trial NCT04767763: Thyroid Function in Critically Ill Patients With Acute Kidney Injury
Official title: Association of Continuous Veno-venous Hemodiafiltration With Citrate Anticoagulation to Thyroid Function in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Hypothyroidism
Keywords: renal replacement therapy
thyroid hormones
acute kidney injury
intensive care unit
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with acute kidney injury and indications for continuous renal replacement therapy without pre-existing end-stage chronic kidney disease or hypothyroidism.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: blood concentrations of thyroid hormones
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdansk - Departament of Anesthesiology and Intensive Care
state: Pomorskie
Study officials:
References: