Colecalciferol for Vitamin D deficiency

Inclusion criteria

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

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Percentage of patients with 25(OH)D3 serum levels ≥30 ng/mL on days 3 and 7 after vitamin D3 administration.","definition_or_measurement_approach":"Serum 25(OH)D3 concentration measured on Days 3 and 7 after administration; endpoint is the percentage of patients achieving ≥30 ng/mL on those days."}

Secondary endpoints

• {"endpoint_text":"- Number of patients who died on day 28 and 90 after administration of vitamin D3 preparation.","definition_or_measurement_approach":"All-cause mortality assessed at Day 28 and Day 90 after IMP administration."}
• {"endpoint_text":"- Duration of treatment in the ICU of patients receiving vitamin D3 preparation.","definition_or_measurement_approach":"Length of ICU stay measured for participants receiving the IMP."}
• {"endpoint_text":"- SOFA score on day 3 and 7 in patients receiving vitamin D3 preparation.","definition_or_measurement_approach":"Sequential Organ Failure Assessment (SOFA) score measured on Days 3 and 7."}
• {"endpoint_text":"- Duration of catecholamine supply in patients receiving vitamin D3.","definition_or_measurement_approach":"Duration (time) of catecholamine administration measured for participants receiving the IMP."}
• {"endpoint_text":"- The CRRT duration in hours from the IMP administration until the visit 4 start.","definition_or_measurement_approach":"Number of hours of continuous renal replacement therapy (CRRT) from IMP administration to start of Visit 4."}
• {"endpoint_text":"- Total gastric residual volume in milliliters from the IMP administration until the visit 3 start.","definition_or_measurement_approach":"Cumulative gastric residual volume (mL) measured from IMP administration until start of Visit 3."}
• {"endpoint_text":"- Safety Assessment Endpoint: Percentage of patients who achieved toxic serum vitamin D3 concentrations (25(OH)D3 ≥150 ng/mL) on Days 3 and 7.","definition_or_measurement_approach":"Serum 25(OH)D3 measured on Days 3 and 7; endpoint is percentage with levels ≥150 ng/mL."}
• {"endpoint_text":"- Safety Assessment Endpoint: Percentage of patients who achieved a serum total calcium concentration (>11 mg/dL) on Days 3 and 7.","definition_or_measurement_approach":"Serum total calcium measured on Days 3 and 7; endpoint is percentage with >11 mg/dL."}

Poland

Earliest CTIS Part Ii Submission Date

23-07-2024

Latest Decision Or Authorization Date

30-09-2025

Processing Time Days

434

Number Of Sites

3

Number Of Participants

138

Primary sponsor

Full Name

Uniwersytecki Szpital Kliniczny W Opolu

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Contract research organisations

Name

Biostat Sp. z o.o.

Responsibilities

Pharmacovigillance, Statistical Analysis, patient randomization (and other sponsor duties listed)

Third parties

• {"country":"Poland","full_name":"Biostat Sp. z o.o.","duties_or_roles":"Pharmacovigillance, Statistical Analysis, patient randomization (sponsor duties codes: 1, 12, 15, 5, 6, 7, 8)","organisation_type":"Non-Pharmaceutical company"}