Efficacy comparison of two doses of vitamin D3 in critically ill patients undergoing continuous renal replacement therapy - NephroD

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 138

Inclusion Criteria

1. Presence of at least one of the following indications for implementation of CRRT by CVVHDF or CVVHF (Clinical Practice Guideline for Acute Kidney Injury):
- replacement of non-functioning kidney function when acute kidney injury occurs
- hyperkalemia
- metabolic acidosis
- pulmonary edema
- complications of uremia (hemorrhagic diathesis, pericarditis)
- hypervolaemia
- Renal function support (control of goiter, acid-base, ion balance)
2. organ failure score (SOFA) of at least 5 at the time of qualification for the study
3. patient age >18 years
4. 25(OH)D3 serum concentration =12.5 ng/ml - test performed by the local laboratory of the participating hospital
5. Properly managed enteral nutrition (through a gastric tuber or orally) at any dose.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 138
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 138

Exclusion Criteria

1. acute or advanced chronic liver failure (estimated by clinical presentation and biochemical markers: serum bilirubin, serum AST and ALT, high AST/ALT serum ratio, glycemia, INR value)
2. hypercalcemia (total calcium >11 mg/dL or >2,7mmol/L )
3. Any parathyroid disease
4. KDIGO classification of end-stage renal disease
5. Patients undergoing plasmapheresis, extracorporeal membrane oxygenation (ECMO), extracorporeal carbon dioxide elimination (ECCO2R)
6. Patients who, in the opinion of the investigator, do not have a good chance of surviving the 72 hour period after study entry
7. history of kidney stones or de novo renal calculi
8. patient eligible for futile therapy avoidance protocol
9. pregnancy
10. sarcoidosis
11. risk of impaired intestinal absorption in critical illness associated with at least one of the mentioned: impaired intestinal motility and delayed gastric emptying, constipation, diarrhea, intestinal hypoperfusion in shock, intoxication with subsequent intestinal edema after fluid resuscitation, changes in the intestinal microbiome.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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