Insufficient Cellular Oxygen in ICU Patients With Anaemia

Insufficient Cellular Oxygen in ICU Patients With Anaemia: the INOX ICU-2 Study

Sponsors

Lead Sponsor: Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research

Collaborator: Leiden University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Erasmus Medical Center

Source Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Brief Summary

The purpose of this study is whether the mitochondrial oxygenation tension (mitoPO2) is a feasible and reliable tool in ICU patients with anaemia undergoing red cell transfusion to ultimately personalize blood transfusion decisions in the ICU.

Detailed Description

Evidence is increasing that in some cases a Hb trigger of 7-8g/dl may be too low and te question arises whether an individualized red cell transfusion strategy may benefit critically ill patients. New studies have shown the potential of protoporphyrin IX-triple state lifetime technique to measure mitochondrial oxygenation tension (mitoPO2) in vivo, which possibly is an early indicator of oxygen disturbance in the cell and therefore a physiological trigger for red cell transfusion. The goals are: 1. Determining the feasibility of using mitoPO2 and the variability of mitoPO2 measurements in critically ill intensive care unit (ICU) patients before and after receiving a red cell transfusion 2. Describing the effects of red cell transfusion and the associated change in [Hb] on mitoPO2 and on other physiologic measures of tissue oxygenation and oxygen balance 3. Describing the association between mitoPO2 and vital organ functions. Included patients will undergo red cell transfusion as planned. However, red cell transfusion will be delayed by 2 hours. At multiple predefined moments data collection including blood samples and measurements of mitoPO2 will take place.

The results of this study cannot be immediately translated to clinical practice. Using these results, the investigators will design a phase 2 diagnostic study, most probably a randomized clinical trial that will yield applied knowledge with respect to personalizing red cell transfusion. Application will be in ICU patients with anaemia who might or might not profit from red cell transfusions. It will lead to a reduction of both over- and under- transfusion.

Overall Status Recruiting
Start Date May 16, 2017
Completion Date December 1, 2020
Primary Completion Date December 1, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Variability of mitoPO2 Variability of mitoPO2 will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study
Secondary Outcome
Measure Time Frame
Organ damage Value of mitoPO2 in predicting (ischemic) organ damage will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study
Microcirculation Association of the mitoPO2 with the microcirculation will be assessed during 2 predefined moments (before transfusion and 24 hours after transfusion) in the study
Length of stay Length of stay will be assessed during the 3 months follow-up time
Mortality Mortality will be assessed during the 3 months follow-up time
Adverse events Association of the mitoPO2 with adverse events will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study
Enrollment 240
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- adult patient admitted to the ICU

- Hb below 6.3 mmol/l (10 g/dl)

- central venous catheter in situ

- red cell transfusion planned

Exclusion Criteria:

- adults without a legal representative to ask for informed consent

- patients less than 18 years old

- pregnant or breast feeding women

- patients in need of emergency red cell transfusion e.g. bleeding

- not having a central venous catheter in situ

- porphyria and or known photodermatosis

- patients with an expected ICU stay <24 hours

- patients with hypersensitivity to the active substance or to the plaster material of ALA

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Meryem Baysan, MD

Phone: +31715297274

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Amsterdam Medical Center | Amsterdam, Amsterdam-Zuidoost, Noord-Holland, 1105 AZ, Netherlands Recruiting N P Juffermans, PhD, MD [email protected] N P Juffermans, PhD, MD Principal Investigator
Leiden University Medical Center | Leiden, Zuid-Holland, 2333 ZA, Netherlands Recruiting M S Arbous, PhD, MD ++31715261678 [email protected] M Baysan, MD Principal Investigator
Erasmus University Medical Center | Rotterdam, Zuid-Holland, 3015 CE, Netherlands Not yet recruiting B Mik, PhD, MD [email protected] B Mik, PhD, MD Principal Investigator
Location Countries

Netherlands

Verification Date

June 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: ICU patients with anaemia

Description: At admission to the ICU all patients, or their legal representatives, expected to stay at the ICU for longer than 24 hours will be asked to participate in the study and will be asked informed consent. ICU patients with anaemia in whom a central venous catheter is already in place and in whom a red cell transfusion is planned, will be included in the study.

Acronym INOX ICU-2
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov