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

Conditions

Vitamin D3 deficiency

Brief summary

Percentage of patients with 25(OH)D3 serum levels ≥30 ng/mL on days 3 and 7 after vitamin D3 administration.

Detailed description

Number of patients who died on day 28 and 90 after administration of vitamin D3 preparation., Duration of treatment in the ICU of patients receiving vitamin D3 preparation., SOFA score on day 3 and 7 in patients receiving vitamin D3 preparation., Duration of catecholamine supply in patients receiving vitamin D3., The CRRT duration in hours from the IMP administration until the visit 4 start., Total gastric residual volume in milliliters from the IMP administration until the visit 3 start., Safety Assessment Endpoint: Percentage of patients who achieved toxic serum vitamin D3 concentrations (25(OH)D3 ≥150 ng/mL) on Days 3 and 7., Safety Assessment Endpoint: Percentage of patients who achieved a serum total calcium concentration (>11 mg/dL) on Days 3 and 7.

Related papers

No related papers found yet.

Papers published before 2007-03-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGDevikap

DRUG15 000 IU/ml

DRUGkrople doustne

DRUGroztwór

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of patients with 25(OH)D3 serum levels ≥30 ng/mL on days 3 and 7 after vitamin D3 administration.	—

Secondary

Measure	Time frame
Number of patients who died on day 28 and 90 after administration of vitamin D3 preparation., Duration of treatment in the ICU of patients receiving vitamin D3 preparation., SOFA score on day 3 and 7 in patients receiving vitamin D3 preparation., Duration of catecholamine supply in patients receiving vitamin D3., The CRRT duration in hours from the IMP administration until the visit 4 start., Total gastric residual volume in milliliters from the IMP administration until the visit 3 start., Safety Assessment Endpoint: Percentage of patients who achieved toxic serum vitamin D3 concentrations (25(OH)D3 ≥150 ng/mL) on Days 3 and 7., Safety Assessment Endpoint: Percentage of patients who achieved a serum total calcium concentration (>11 mg/dL) on Days 3 and 7.	—

Measure

Time frame

Number of patients who died on day 28 and 90 after administration of vitamin D3 preparation., Duration of treatment in the ICU of patients receiving vitamin D3 preparation., SOFA score on day 3 and 7 in patients receiving vitamin D3 preparation., Duration of catecholamine supply in patients receiving vitamin D3., The CRRT duration in hours from the IMP administration until the visit 4 start., Total gastric residual volume in milliliters from the IMP administration until the visit 3 start., Safety Assessment Endpoint: Percentage of patients who achieved toxic serum vitamin D3 concentrations (25(OH)D3 ≥150 ng/mL) on Days 3 and 7., Safety Assessment Endpoint: Percentage of patients who achieved a serum total calcium concentration (>11 mg/dL) on Days 3 and 7.

—

Countries

Poland

Outcome results

None listed