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

Phase 1

• Conditions: Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]; Vitamin D3 deficiency; MedDRA version: 20.0Level: PTClassification code: 10047626Term: Vitamin D deficiency Class: 100000004861

• Registration Number: CTIS2024-510834-42-00
• Lead Sponsor: niwersytecki Szpital Kliniczny W Opolu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-08
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

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), Organ failure score (SOFA) of at least 5 at the time of qualification for the study, Patient age >18 years, 25(OH)D3 serum concentration =12.5 ng/ml - test performed by the local laboratory of the participating hospital, Properly managed enteral nutrition (through a gastric tuber or orally) at any dose.

Exclusion Criteria

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), Sarcoidosis, 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., Hypercalcemia (total calcium >11 mg/dL or >2,7mmol/L), Any parathyroid disease, KDIGO classification of end-stage renal disease, Patients undergoing plasmapheresis, extracorporeal membrane oxygenation (ECMO), extracorporeal carbon dioxide elimination (ECCO2R), Patients who, in the opinion of the investigator, do not have a good chance of surviving the 72 hour period after study entry, History of kidney stones or de novo renal calculi, Patient eligible for futile therapy avoidance protocol, Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified