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临床试验/NCT03314363
NCT03314363已完成不适用

MEtabolic Consequences of Continuous Renal Replacement Therapy and Impact on Indirect cAlorimetry Study

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年4月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
change in CO2 flow and O2 flow on different sample points of CRRT

研究概览

简要总结

The aim of the present study is to assess the metabolic impact of Continuous Renal Replacement Therapy and overview the obstacles and important factors compromising the use of Indirect Calorimetry in CRRT and suggest a model to overcome these issues.

详细描述

Acute kidney injury (AKI) complicates a critical illness from 13% up to 78%, needing renal replacement therapy (RRT) up to10 % of all patients in the intensive care unit (ICU). Both intermittent (IRRT) and continuous renal replacement therapy (CRRT) are used. The advantage of the latter is that it has lesser influence on hemodynamics and is better tolerated in critical ill patients.

Another complication during their stay is the inability to feed themselves. Nutrition is a cornerstone in the care for the critical ill and should be started within 3 days of admission to the intensive care unit. To optimize a nutritional prescription, protein and energy targets need to be defined. Predicting formulae based on anthropometric measures and other parameters can be used to calculate the caloric need but indirect calorimetry (IC) remains the gold standard. Caloric need can be derived from Energy expenditure which is calculated with the Weir's equation using carbon dioxide (CO2) production (VCO2) and oxygen (O2) consumption (VO2). Therefore, it is underestimated if CO2 is lost through other means than the normal respiratory route. Hence one of the contra-indications of IC is CRRT.

The totalCO2 (tCO2) travels through the vascular structures within the red blood cells or inside plasma. There, most of the content has 3 different forms: as physically dissolved CO2, bicarbonate, and carbamino compounds. These compounds are in equilibrium with each other. During RRT, a potential loss of CO2 and its different forms may occur due to ultrafiltration in the dialysate. No large trials were conducted trying to quantify this loss nor identifying the determining factors which can be used to predict this loss. Indeed, one author even found a gain in tCO2 of the blood during dialysis with acetate. Trisodiumcitrate is used as an anticoagulant during CRRT. It is a weak base and due to pH change may alter the equilibrium of the Henderson-Hasselbalch equation and thus influence the balance between CO2 and HCO3- and its extraction through CRRT.

Although indirect calorimetry in the intensive care unit has been evaluated during CRRT, the loss of tCO2was not considered. The investigators explored the possibility to predict and easily calculate this CO2 exchange so IC can be used during CRRT.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • AKI requiring CRRT
  • Patient on CRRT who's filter you want to change
  • Expected stable patient during the test ( +- 2h) evaluated at discretion of physician :
  • No alteration in medication
  • Stable respiratory settings where no change in conditions is expected. If possible, controlled mode ventilation is preferred.
  • Expected stable pH and lactate
  • no intervention will be made on patient (transport/washing/physiotherapy/...)
  • no alterations on settings of CRRT is expected to be made.
  • Maximal respiratory settings: max FiO2: 60% / max inspiratory plateau pressure 30 mmHg/max tidal volumes 8ml/kg
  • pH between 7,30-7,50, lactate levels <2,0
  • starting settings CRRT with citrate:
  • Blood pump flow: 150 ml/min
  • Predilution ( citrate): 1500-2300ml/h
  • Dialysate dose: 25-40 ml/kg/h
  • ultrafiltration: 0-300 ml /h
  • Substitution: NaCl 300-800 ml/h or B22: 400-2000 ml/h

排除标准

  • Pregnancy / lactation
  • Contra-indications for the use of indirect calorimetry as stated by the AARC (FiO2>60%, chest tubes)
  • Severe hemodynamic or ventilator instability.
  • CRRT modalities unusual to daily clinical ICU practice

研究组 & 干预措施

all patients

Other

Classic CRRT with citrate predilution

干预措施: blood gas analysis under citrate predilution (Diagnostic Test)

all patients

Other

Classic CRRT with citrate predilution

干预措施: filter replacement (Device)

all patients

Other

Classic CRRT with citrate predilution

干预措施: IC (Device)

all patients

Other

Classic CRRT with citrate predilution

干预措施: NaCl predilution (Drug)

all patients

Other

Classic CRRT with citrate predilution

干预措施: blood gas analysis under NaCl predilution (Diagnostic Test)

all patients

Other

Classic CRRT with citrate predilution

干预措施: double ultrafiltration (Drug)

all patients

Other

Classic CRRT with citrate predilution

干预措施: blood gas analysis under citrate predilution and double ultrafiltration rate (Diagnostic Test)

all patients

Other

Classic CRRT with citrate predilution

干预措施: pause and restart nutritional therapy (Dietary Supplement)

all patients

Other

Classic CRRT with citrate predilution

干预措施: evolution of vitamin and trace elements (Diagnostic Test)

结局指标

主要结局

change in CO2 flow and O2 flow on different sample points of CRRT

时间窗: 2hours

CO2 flow and O2 flow ( ml/min) will be compared between the different sample points on CRRT with and without citrate. CO2 flow and O2 flow is calculated by multiplying fluid flow ( ml/min) on different sample points of CRRT with CO2 content or O2 content of fluid on respective sample points during CRRT with and without Citrate.

does change in CO2 flow and O2 flow on different sample points of CRRT correlate with VCO2 and VO2 change due to CRRT with or without citrate

时间窗: 2 hours

VCO2 and VO2 change due to CRRT and due to citrate will be correlated with change in CO2 and O2 flow of fluids passing through CRRT with or without citrate.

REE change due to CRRT

时间窗: 2hours

REE ( Kcal) will be measured during the whole procedure using IC. REE will be measured during CRRT. citrate wil be replaced by NaCl 0,9% fluid and REE will be measured. After this, CRRT will be stopped and REE will be measured. The difference in REE during CRRT with and without citrate and without CRRT will be calculated and compared. REE is calculated using the weir equation and VO2, VCO2. VO2 and VCO2 is calculated using FiO2, FeO2, FiCO2, FeCO2 and VE.

Are vitamins and trace elements sufficiently supplemented with standard nutritional therapy during CRRT

时间窗: 24hours

blood analysis for concentrations of Vitamin A, B1, B6, B9, B12, C, D, E ; trace elements selenium, zinc, copper, chrome; and cholesterol and triglyceride

次要结局

  • change in bicarbonate content of fluid passing through CRRT(2hours)
  • VCO2 and VO2 change due to CRRT with or without citrate(2 hours)
  • change in CO2 and O2 content of fluid passing through CRRT(2hours)
  • change in pH change of fluid passing through CRRT(2hours)
  • VE change due to CRRT with or without citrate(2hours)
  • change in pCO2 and pO2 change of fluid passing through CRRT(2hours)
  • FiO2, FeO2, FiCO2 and FeCO2 change due to CRRT with or without citrate(2hours)

研究者

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

Elisabeth De Waele

Principal Investigator, clinical professor

Universitair Ziekenhuis Brussel

研究点 (1)

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