2024-510834-42-00招募中4 期
Efficacy comparison of two doses of vitamin D3 in critically ill patients undergoing continuous renal replacement therapy - NephroD
Uniwersytecki Szpital Kliniczny W Opolu3 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2024年8月9日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 3
- 主要终点
- Percentage of patients with 25(OH)D3 serum levels ≥30 ng/mL on days 3 and 7 after vitamin D3 administration.
研究概览
简要总结
To evaluate and compare the effect of two different supplementation doses of vitamin D3 (25 (OH) D3) - 500,000 IU and 750,000 IU on the serum concentration of 25 (OH) D3 administered once enterally (througha gastric tuber or orally) in ICU patients with severe vitamin D3 deficiency undergoing continuous renal replacement therapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Percentage of patients with 25(OH)D3 serum levels ≥30 ng/mL on days 3 and 7 after vitamin D3 administration.
Percentage of patients with 25(OH)D3 serum levels ≥30 ng/mL on days 3 and 7 after vitamin D3 administration.
次要结局
- 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.
研究者
USK w Opolu
Scientific
Uniwersytecki Szpital Kliniczny W Opolu
研究点 (3)
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