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

NCT03314363 | Completed

• 1 other identifier: B.U.N. 143201731636
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Continuous Renal Replacement Therapy; CO2 Removal; Nutrition Poor; Acute Renal Failure

Keywords

Calorimetry, Indirect; respiratory dialysis

Outcome Measures

Primary Outcomes (4)

• 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.

  2hours

• 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.

  2hours

• 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.

  2 hours

• 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

  24hours

Secondary Outcomes (7)

• VCO2 and VO2 change due to CRRT with or without citrate

  2 hours

• FiO2, FeO2, FiCO2 and FeCO2 change due to CRRT with or without citrate

  2hours

• VE change due to CRRT with or without citrate

  2hours

• change in CO2 and O2 content of fluid passing through CRRT

  2hours

• change in bicarbonate content of fluid passing through CRRT

  2hours

Study Arms (1)

all patients

OTHER

Classic CRRT with citrate predilution

Diagnostic Test: blood gas analysis under citrate predilution; Device: filter replacement; Device: IC; Drug: NaCl predilution; Diagnostic Test: blood gas analysis under NaCl predilution; Drug: double ultrafiltration; Diagnostic Test: blood gas analysis under citrate predilution and double ultrafiltration rate; Dietary Supplement: pause and restart nutritional therapy; Diagnostic Test: evolution of vitamin and trace elements

Interventions

blood gas analysis under citrate predilution DIAGNOSTIC_TEST

blood gas analysis of blood on different sample points and dialysis fluid

all patients

filter replacement DEVICE

Using local protocol: stop and disconnect CRRT, replace filter and reconnect and restart CRRT.

all patients

IC DEVICE

monitor patients during the whole study period with indirect calorimetry

all patients

NaCl predilution DRUG

Replace citrate predilution with NaCl

all patients

blood gas analysis under NaCl predilution DIAGNOSTIC_TEST

repeat blood gas analysis of blood on different sample points and dialysis fluid

all patients

double ultrafiltration DRUG

double the ultrafiltration fluid by augmenting post dilution fluid and keeping ultrafiltration at the same rate.

all patients

blood gas analysis under citrate predilution and double ultrafiltration rate DIAGNOSTIC_TEST

repeat blood gas analysis of blood on different sample points and dialysis fluid

all patients

pause and restart nutritional therapy DIETARY_SUPPLEMENT

pause parenteral and enteral nutrition before indirect calorimetry is performed. and restart after first blood analysis for vitamine status

all patients

evolution of vitamin and trace elements DIAGNOSTIC_TEST

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.

all patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

universitair ziekenhuis Brussel

Brussels, 1090, Belgium

Location

Related Publications (12)

• 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.

  PMID: 23573420 RESULT

• 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.

  PMID: 12352040 RESULT

• 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.

  PMID: 17636735 RESULT

• 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.

  PMID: 19505748 RESULT

• 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.

  PMID: 25610953 RESULT

• 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.

  PMID: 27373497 RESULT

• 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.

  PMID: 23689499 RESULT

• 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.

  PMID: 10146137 RESULT

• 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.

  PMID: 6433099 RESULT

• 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.

  PMID: 14624937 RESULT

• 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.

  PMID: 27222413 RESULT

• 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.

  PMID: 31208356 DERIVED

MeSH Terms

Conditions

Malnutrition; Acute Kidney Injury

Interventions

Trace Elements

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Elements; Inorganic Chemicals; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Elisabeth De Waele, Phd

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, clinical professor

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: October 19, 2017
• Study Start: April 26, 2017
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)