两种剂量维生素 D3 在接受连续肾脏替代治疗（NephroD）的危重症患者中的比较：一项单盲、多中心、平行组随机对照试验的研究方案。

Comparison of two doses of vitamin D3 in critically ill patients undergoing continuous renal replacement therapy (NephroD): study protocol for a single-blinded, multicenter, parallel group randomized controlled trial.

机构信息

Department of Anesthesiology, Intensive Care and Regional ECMO Center, Institute of Medical Sciences, University of Opole, Opole, Poland.

Department of Anesthesiology and Intensive Care, Faculty of Medical Sciences in Zabrze, Medical University of Silesia in Katowice, Katowice, Poland.

出版信息

Trials. 2024 Nov 24;25(1):791. doi: 10.1186/s13063-024-08598-5.

DOI:10.1186/s13063-024-08598-5

PMID:39582029

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11587676/

Abstract

BACKGROUND

ICU patients are particularly susceptible to vitamin D3 deficiencies. This can be due to the severity of their underlying disease, the type of treatment they are on, and malnutrition before and inadequate nutrition during the hospitalization preceding ICU admission as well as advanced age. Literature provides no guidance on how to supplement vitamin D3 in severely deficient patients who are undergoing continuous renal replacement therapy (CRRT). Most serum 25(OH)D3 is bound with vitamin D binding protein in a complex whose molecular weight is 10 kDa. This means it can be removed during CRRT via convection mechanism. Critically ill patients undergoing CRRT can therefore be particularly prone to develop severe vitamin D3 deficiency.

METHODS

As the trial design, a randomized controlled, single blinded, multicenter, parallel group approach was chosen to compare a single administration of 750,000 IU of vitamin D3 via the enteral or oral route in ICU patients with severe vitamin D3 deficiency (measured serum 25(OH)D3 levels ≤ 12.5 ng/ml) undergoing CRRT with a single administration of 500,000 IU of vitamin D3. The trial will be performed in up to five university hospitals in Poland. The primary outcome is the percentage of patients that achieved serum 25(OH)D3 levels ≥ 30 ng/ml on days 3 and 7 following vitamin D3 administration. Assuming a drop-out rate of approximately 10%, the number of recruited patients should be 138.

DISCUSSION

Considering the potential pathophysiological mechanisms underlying hypovitaminosis D in critically ill patients under CRRT, it seems conceivable that these patients will require greater supplementation doses to correct severe deficiency. The study is meant to help answer the question whether increasing the supplementation dose by 50% will ensure a more effective replenishment of vitamin D3 in critically ill patients undergoing CRRT.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT05657678, registered: December 12 2022, https://clinicaltrials.gov/study/NCT05657678?cond=NCT05657678&rank=1 .

摘要

背景

ICU 患者特别容易出现维生素 D3 缺乏。这可能是由于他们基础疾病的严重程度、所接受的治疗类型、入住 ICU 前的营养不良以及住院期间的营养不足以及年龄较大。文献没有提供关于正在接受连续肾脏替代治疗（CRRT）的严重缺乏维生素 D3 的患者如何补充维生素 D3 的指导。大多数血清 25(OH)D3 与维生素 D 结合蛋白结合形成分子量为 10 kDa 的复合物。这意味着它可以通过对流机制在 CRRT 期间被清除。因此，接受 CRRT 的危重症患者特别容易出现严重的维生素 D3 缺乏。

方法

由于试验设计，选择了一项随机对照、单盲、多中心、平行组研究，比较了经肠或口服途径单次给予 750,000 IU 维生素 D3 与单次给予 500,000 IU 维生素 D3 治疗在接受 CRRT 的严重维生素 D3 缺乏症（测量血清 25(OH)D3 水平≤12.5 ng/ml）的 ICU 患者中的作用。该试验将在波兰的五所大学医院进行。主要结局是在维生素 D3 给药后第 3 天和第 7 天达到血清 25(OH)D3 水平≥30 ng/ml 的患者百分比。假设大约 10%的患者脱落，应招募的患者数量应为 138 例。