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Plasma CO2 Removal Due to CRRT and Its Influence on Indirect Calorimetry (MECCIAS)

Primary Purpose

Continuous Renal Replacement Therapy, CO2 Removal, Nutrition Poor

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
blood gas analysis under citrate predilution
filter replacement
IC
NaCl predilution
blood gas analysis under NaCl predilution
double ultrafiltration
blood gas analysis under citrate predilution and double ultrafiltration rate
pause and restart nutritional therapy
evolution of vitamin and trace elements
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Continuous Renal Replacement Therapy focused on measuring Calorimetry, Indirect, respiratory dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • universitair ziekenhuis Brussel

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

all patients

Arm Description

Classic CRRT with citrate predilution

Outcomes

Primary Outcome Measures

change in CO2 flow and O2 flow on different sample points of CRRT
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.
REE change due to CRRT
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.
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
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.
Are vitamins and trace elements sufficiently supplemented with standard nutritional therapy during CRRT
blood analysis for concentrations of Vitamin A, B1, B6, B9, B12, C, D, E ; trace elements selenium, zinc, copper, chrome; and cholesterol and triglyceride

Secondary Outcome Measures

VCO2 and VO2 change due to CRRT with or without citrate
VCO2 and VO2 ( ml/min) will be measured during the whole procedure using IC. VCO2 and VO2 will be measured during CRRT with citrate. citrate wil be replaced by NaCl 0,9% fluid and VCO2 and VO2 will be measured. After this, CRRT will be stopped and VCO2 and VO2 will be measured. The difference in VCO2 and VO2 during CRRT with or without citrate and without CRRT will be calculated and compared. VO2 and VCO2 is calculated using FiO2, FeO2, FiCO2, FeCO2 and VE.
FiO2, FeO2, FiCO2 and FeCO2 change due to CRRT with or without citrate
FiO2, FeO2, FiCO2 and FeCO2 ( %) will be measured during the whole procedure using IC. FiO2, FeO2, FiCO2 and FeCO2 will be measured during CRRT with citrate. citrate wil be replace by NaCl0,9% fluid and FiO2, FeO2, FiCO2 and FeCO2 will be measured. After this CRRT will be stopped and FiO2, FeO2, FiCO2 and FeCO2 will be measured. The difference in FiO2, FeO2, FiCO2 and FeCO2 during CRRT with or without citrate and without CRRT will be calculated.
VE change due to CRRT with or without citrate
VE( ml/min) will be measured during the whole procedure using IC. VE will be measured during CRRT with citrate. citrate wil be replace by NaCl0,9% fluid and VE will be measured. After this CRRT will be stopped and VE will be measured. The difference in VE during CRRT with or without citrate and without CRRT will be calculated.
change in CO2 and O2 content of fluid passing through CRRT
using blood gas analyser, CO2 content and O2content ( mmol/L)of fluid on different sample points in extracorporeal circuit of CRRT with or without citrate will be analysed and compared.
change in bicarbonate content of fluid passing through CRRT
using blood gas analyser, bicarbonate ( mmol/L) of fluid on different sample points in extracorporeal circuit of CRRT with or without citrate will be analysed and compared.
change in pH change of fluid passing through CRRT
using blood gas analyser, pH of fluid on different sample points in extracorporeal circuit of CRRT with or without citrate will be analysed and compared
change in pCO2 and pO2 change of fluid passing through CRRT
using blood gas analyser, pCO2 and pO2 (mmHg) of fluid on different sample points in extracorporeal circuit of CRRT with or without citrate will be analysed and compared.

Full Information

First Posted
July 3, 2017
Last Updated
May 17, 2022
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT03314363
Brief Title
Plasma CO2 Removal Due to CRRT and Its Influence on Indirect Calorimetry
Acronym
MECCIAS
Official Title
MEtabolic Consequences of Continuous Renal Replacement Therapy and Impact on Indirect cAlorimetry Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 26, 2017 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Continuous Renal Replacement Therapy, CO2 Removal, Nutrition Poor, Acute Renal Failure
Keywords
Calorimetry, Indirect, respiratory dialysis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
all patients
Arm Type
Other
Arm Description
Classic CRRT with citrate predilution
Intervention Type
Diagnostic Test
Intervention Name(s)
blood gas analysis under citrate predilution
Intervention Description
blood gas analysis of blood on different sample points and dialysis fluid
Intervention Type
Device
Intervention Name(s)
filter replacement
Intervention Description
Using local protocol: stop and disconnect CRRT, replace filter and reconnect and restart CRRT.
Intervention Type
Device
Intervention Name(s)
IC
Intervention Description
monitor patients during the whole study period with indirect calorimetry
Intervention Type
Drug
Intervention Name(s)
NaCl predilution
Intervention Description
Replace citrate predilution with NaCl
Intervention Type
Diagnostic Test
Intervention Name(s)
blood gas analysis under NaCl predilution
Intervention Description
repeat blood gas analysis of blood on different sample points and dialysis fluid
Intervention Type
Drug
Intervention Name(s)
double ultrafiltration
Intervention Description
double the ultrafiltration fluid by augmenting post dilution fluid and keeping ultrafiltration at the same rate.
Intervention Type
Diagnostic Test
Intervention Name(s)
blood gas analysis under citrate predilution and double ultrafiltration rate
Intervention Description
repeat blood gas analysis of blood on different sample points and dialysis fluid
Intervention Type
Dietary Supplement
Intervention Name(s)
pause and restart nutritional therapy
Intervention Description
pause parenteral and enteral nutrition before indirect calorimetry is performed. and restart after first blood analysis for vitamine status
Intervention Type
Diagnostic Test
Intervention Name(s)
evolution of vitamin and trace elements
Intervention Description
blood analysis for vitamin and trace elements. Perform this blood analysis after restart of CRRT but before restart of nutritional therapy, 30 minutes after restart of nutritional therapy and 24h after restart of nutritional therapy.
Primary Outcome Measure Information:
Title
change in CO2 flow and O2 flow on different sample points of CRRT
Description
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.
Time Frame
2hours
Title
REE change due to CRRT
Description
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.
Time Frame
2hours
Title
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
Description
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.
Time Frame
2 hours
Title
Are vitamins and trace elements sufficiently supplemented with standard nutritional therapy during CRRT
Description
blood analysis for concentrations of Vitamin A, B1, B6, B9, B12, C, D, E ; trace elements selenium, zinc, copper, chrome; and cholesterol and triglyceride
Time Frame
24hours
Secondary Outcome Measure Information:
Title
VCO2 and VO2 change due to CRRT with or without citrate
Description
VCO2 and VO2 ( ml/min) will be measured during the whole procedure using IC. VCO2 and VO2 will be measured during CRRT with citrate. citrate wil be replaced by NaCl 0,9% fluid and VCO2 and VO2 will be measured. After this, CRRT will be stopped and VCO2 and VO2 will be measured. The difference in VCO2 and VO2 during CRRT with or without citrate and without CRRT will be calculated and compared. VO2 and VCO2 is calculated using FiO2, FeO2, FiCO2, FeCO2 and VE.
Time Frame
2 hours
Title
FiO2, FeO2, FiCO2 and FeCO2 change due to CRRT with or without citrate
Description
FiO2, FeO2, FiCO2 and FeCO2 ( %) will be measured during the whole procedure using IC. FiO2, FeO2, FiCO2 and FeCO2 will be measured during CRRT with citrate. citrate wil be replace by NaCl0,9% fluid and FiO2, FeO2, FiCO2 and FeCO2 will be measured. After this CRRT will be stopped and FiO2, FeO2, FiCO2 and FeCO2 will be measured. The difference in FiO2, FeO2, FiCO2 and FeCO2 during CRRT with or without citrate and without CRRT will be calculated.
Time Frame
2hours
Title
VE change due to CRRT with or without citrate
Description
VE( ml/min) will be measured during the whole procedure using IC. VE will be measured during CRRT with citrate. citrate wil be replace by NaCl0,9% fluid and VE will be measured. After this CRRT will be stopped and VE will be measured. The difference in VE during CRRT with or without citrate and without CRRT will be calculated.
Time Frame
2hours
Title
change in CO2 and O2 content of fluid passing through CRRT
Description
using blood gas analyser, CO2 content and O2content ( mmol/L)of fluid on different sample points in extracorporeal circuit of CRRT with or without citrate will be analysed and compared.
Time Frame
2hours
Title
change in bicarbonate content of fluid passing through CRRT
Description
using blood gas analyser, bicarbonate ( mmol/L) of fluid on different sample points in extracorporeal circuit of CRRT with or without citrate will be analysed and compared.
Time Frame
2hours
Title
change in pH change of fluid passing through CRRT
Description
using blood gas analyser, pH of fluid on different sample points in extracorporeal circuit of CRRT with or without citrate will be analysed and compared
Time Frame
2hours
Title
change in pCO2 and pO2 change of fluid passing through CRRT
Description
using blood gas analyser, pCO2 and pO2 (mmHg) of fluid on different sample points in extracorporeal circuit of CRRT with or without citrate will be analysed and compared.
Time Frame
2hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth De Waele, Phd
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
universitair ziekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23573420
Citation
Case J, Khan S, Khalid R, Khan A. Epidemiology of acute kidney injury in the intensive care unit. Crit Care Res Pract. 2013;2013:479730. doi: 10.1155/2013/479730. Epub 2013 Mar 21.
Results Reference
result
PubMed Identifier
12352040
Citation
Metnitz PG, Krenn CG, Steltzer H, Lang T, Ploder J, Lenz K, Le Gall JR, Druml W. Effect of acute renal failure requiring renal replacement therapy on outcome in critically ill patients. Crit Care Med. 2002 Sep;30(9):2051-8. doi: 10.1097/00003246-200209000-00016.
Results Reference
result
PubMed Identifier
17636735
Citation
Rabindranath K, Adams J, Macleod AM, Muirhead N. Intermittent versus continuous renal replacement therapy for acute renal failure in adults. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003773. doi: 10.1002/14651858.CD003773.pub3.
Results Reference
result
PubMed Identifier
19505748
Citation
Singer P, Berger MM, Van den Berghe G, Biolo G, Calder P, Forbes A, Griffiths R, Kreyman G, Leverve X, Pichard C, ESPEN. ESPEN Guidelines on Parenteral Nutrition: intensive care. Clin Nutr. 2009 Aug;28(4):387-400. doi: 10.1016/j.clnu.2009.04.024. Epub 2009 Jun 7.
Results Reference
result
PubMed Identifier
25610953
Citation
Wichansawakun S, Meddings L, Alberda C, Robbins S, Gramlich L. Energy requirements and the use of predictive equations versus indirect calorimetry in critically ill patients. Appl Physiol Nutr Metab. 2015 Feb;40(2):207-10. doi: 10.1139/apnm-2014-0276. Epub 2014 Oct 27.
Results Reference
result
PubMed Identifier
27373497
Citation
Oshima T, Berger MM, De Waele E, Guttormsen AB, Heidegger CP, Hiesmayr M, Singer P, Wernerman J, Pichard C. Indirect calorimetry in nutritional therapy. A position paper by the ICALIC study group. Clin Nutr. 2017 Jun;36(3):651-662. doi: 10.1016/j.clnu.2016.06.010. Epub 2016 Jun 22.
Results Reference
result
PubMed Identifier
23689499
Citation
Honore PM, De Waele E, Jacobs R, Mattens S, Rose T, Joannes-Boyau O, De Regt J, Verfaillie L, Van Gorp V, Boer W, Collin V, Spapen HD. Nutritional and metabolic alterations during continuous renal replacement therapy. Blood Purif. 2013;35(4):279-84. doi: 10.1159/000350610. Epub 2013 May 8.
Results Reference
result
PubMed Identifier
10146137
Citation
AARC clinical practice guideline. Metabolic measurement using indirect calorimetry during mechanical ventilation. American Association for Respiratory Care. Respir Care. 1994 Dec;39(12):1170-5. No abstract available.
Results Reference
result
PubMed Identifier
6433099
Citation
Bosch JP, Glabman S, Moutoussis G, Belledonne M, von Albertini B, Kahn T. Carbon dioxide removal in acetate hemodialysis: effects on acid base balance. Kidney Int. 1984 May;25(5):830-7. doi: 10.1038/ki.1984.97.
Results Reference
result
PubMed Identifier
14624937
Citation
Scheinkestel CD, Kar L, Marshall K, Bailey M, Davies A, Nyulasi I, Tuxen DV. Prospective randomized trial to assess caloric and protein needs of critically Ill, anuric, ventilated patients requiring continuous renal replacement therapy. Nutrition. 2003 Nov-Dec;19(11-12):909-16. doi: 10.1016/s0899-9007(03)00175-8.
Results Reference
result
PubMed Identifier
27222413
Citation
Wu C, Wang X, Yu W, Li P, Liu S, Li J, Li N. Short-term consequences of continuous renal replacement therapy on body composition and metabolic status in sepsis. Asia Pac J Clin Nutr. 2016;25(2):300-7. doi: 10.6133/apjcn.2016.25.2.29.
Results Reference
result
PubMed Identifier
31208356
Citation
Jonckheer J, Spapen H, Debain A, Demol J, Diltoer M, Costa O, Lanckmans K, Oshima T, Honore PM, Malbrain M, De Waele E. CO2 and O2 removal during continuous veno-venous hemofiltration: a pilot study. BMC Nephrol. 2019 Jun 17;20(1):222. doi: 10.1186/s12882-019-1378-y. Erratum In: BMC Nephrol. 2019 Aug 8;20(1):312.
Results Reference
derived

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Plasma CO2 Removal Due to CRRT and Its Influence on Indirect Calorimetry

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