Last updated: April 21, 2024
Sponsor: Uniwersytecki Szpital Kliniczny w Opolu
Overall Status: Active - Recruiting
Phase
4
Condition
N/ATreatment
Vitamin D3 - 750 000 IU
Vitamin D3 - 500 000 IU
Clinical Study ID
NCT05657678
NephroD_2021
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Presence of the following indications for initiation of CRRT with CVVHDF or CVVHF (acc. to KDIGO, Clinical Practice Guideline for Acute Kidney Injury):
- replacement of kidney function in acute kidney injury
- hyperkalaemia
- metabolic acidosis
- pulmonary oedema
- uraemic complications (bleeding disorder, pericarditis)
- hypervolaemia
- support of renal function (volume control, regulation of acid-base andelectrolyte status)
- Sequential Organ Failure Assessment (SOFA) score of minimum 5 points at enrolment
- Age of >18 years
- Plasma 25(OH)D3 levels ≤12.5 ng/ml as measured by the local laboratory of aparticipating hospital
- Properly managed enteral nutrition regardless of dosing
Exclusion
Exclusion Criteria:
- Acute or advanced chronic liver failure (estimated on the basis of the clinicalpicture and biochemical markers: plasma bilirubin, plasma AST and ALT, high plasmaAST/ALT ratio, glycaemia, INR)
- Hypercalcaemia (total calcium concentration >11 mg/dl)
- Any parathyroid disorder
- End stage renal disease according to the KDIGO classification
- Patients undergoing plasmapheresis, extracorporeal membrane oxygenation (ECMO),extracorporeal carbon dioxide removal (ECCO2R)
- Patients who, in the opinion of the investigator, are not expected to survive 72 hourssince enrolment
- A history of nephrolithiasis or de novo nephrolithiasis
- Patient qualified to a protocol for the avoidance of futile therapy
- Pregnancy
- Sarcoidosis
- Risk of impaired intestinal absorption caused by the critical illness, associated withimpaired peristalsis and delayed gastric emptying, constipation, diarrhoea,shock-induced intestinal hypoperfusion, hyperhydration with resulting intestinaloedema following fluid resuscitation, intestinal flora disorders.
Study Design
Total Participants: 138
Treatment Group(s): 2
Primary Treatment: Vitamin D3 - 750 000 IU
Phase: 4
Study Start date:
December 20, 2022
Estimated Completion Date:
May 01, 2026
Connect with a study center
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Opolskie 45-401
PolandActive - Recruiting
5 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
Krakow,
PolandActive - Recruiting
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin,
PolandActive - Recruiting
Samodzielny Publiczny Szpital Kliniczny nr 1 Śląski Uniwersytet Medyczny w Katowicach
Zabrze, 41-800
PolandActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.