NCT04767763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 17, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

12 months

First QC Date

February 17, 2021

Last Update Submit

February 22, 2021

Conditions

Secondary Hypothyroidism

Keywords

renal replacement therapythyroid hormonesacute kidney injuryintensive care unit

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Patients with Acute Kidney Injury

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.

Diagnostic Test: Assessment of TSH, fT3, fT4,TRH, TT3, TT4, rT3 in patients with CVVHDF

Interventions

Assessment of TSH, fT3, fT4,TRH, TT3, TT4, rT3 in patients with CVVHDFDIAGNOSTIC_TEST

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.

Patients with Acute Kidney Injury

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Gdansk - Departament of Anesthesiology and Intensive Care

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

HypothyroidismAcute Kidney Injury

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 23, 2021

Study Start

February 19, 2019

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

PL(1)