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临床试验/NCT03976440
NCT03976440Unknown不适用

Simplified Regional Citrate Anticoagulation Protocols for CVVH, CVVHDF and SLED Focused on the Prevention of RRT-related Hypophosphatemia and Optimization of Acid-base Balance: a Pilot Study

University of Parma1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Hypophosphatemia

研究概览

简要总结

The aim of the study are: 1) To evaluate the occurrence of acid-base alterations and the incidence of hypophosphatemia during different modalities of Renal Replacement Terapy (RRT) in critically ill patients [CVVH, CVVHDF and SLED (Sustained Low-Efficiency Dialysis)] by using a simplified Regional Citrate Anticoagulation (RCA) protocol combined with the adoption of a phosphate-containing solution as dialysate and/or replacement fluid; 2) To optimize the infusion rates of different solutions adopted, including citrate, in order to obtain an appropriate electrolyte and buffer supply. The final aim of this approach will be to reduce the need for frequent monitoring of acid-base status and electrolytes (with special regard to ionized calcium levels), and to avoid the need for frequent adjustments of RCA-RRT parameters (infusion rate of different solutions, electrolytes supplementation in the course of RRT). This approach could allow to simplify anticoagulation protocols with citrate, in order to minimize potential concerns hampering a wider diffusion of RCA in daily practice.

详细描述

The need for continuous anticoagulation represents a potential drawback of RRT modalities. KDIGO 2012 guidelines on acute kidney injury (AKI) suggest the adoption of RCA as first choice anticoagulation modality for continuous RRT (CRRT) in patients without contraindications for citrate. Citrate has been also introduced as anticoagulant for SLED and its use in the context of a mainly diffusive prolonged intermittent modality has been shown to represent an easy and safe method to maintain the extracorporeal circuit when concentrated citrate solutions, such as ACD-A are used. Hypophosphatemia is a known issue of RRT, and has been reported in up to 50-80% of cases when standard RRT solutions are used, especially in continuous/prolonged intermitted modalities when high RRT doses are delivered. RRT-related phosphate depletion should be avoided in critically ill patients due to the relevant hypophosphatemia-associated complications in this clinical setting. The adoption of phosphate-containing CRRT solutions could reduce the incidence of hypophosphatemia and minimize the need for parenteral phosphorus supplementation.The adoption of a commercially available phosphate-containing CRRT solution, in the setting of RCA-RRT may allow to meet the double target of minimizing RRT-induced hypophosphatemia and ensuring an adequate circuit life, also avoiding electrolyte and acid-base derangements.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age >= 18 years
  • critically ill patients requiring continuous or prolonged intermittent renal replacement therapy for severe acute kidney injury (AKI)
  • critically ill patients requiring continuous or prolonged intermittent renal replacement therapy for end stage renal disease (ESRD)

排除标准

  • age < 18 years

结局指标

主要结局

Hypophosphatemia

时间窗: 72 hours

Occurrence of hypophosphatemia during the first 72 hours of continuous renal replacement therapy (CRRT) or sustained low-efficiency dialysis (SLED)

Variations of RCA-RRT solutions

时间窗: 72 hours

Evaluation of the need for variations in RRT solutions flow rate rom initial RRT settings

Acid-base derangements

时间窗: 72 hours

Occurrence of acid-base derangements during CRRT and SLED using a simplified RCA protocol

Variations of RCA-RRT parameters

时间窗: 72 hours

Evaluation of the need for variations of RCA-RRT dialysis parameters from initial RRT settings

次要结局

  • Efficacy of RCA(72 hours)
  • Hypomagnesemia(72 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Enrico Fiaccadori

University Professor

University of Parma

研究点 (1)

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