Insufficient Cellular Oxygen in ICU Patients With Anaemia

NCT03092297 | Terminated DMC

• 1 other identifier: NL59512.058.16
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 2

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.

Conditions

Critical Care; Anemia; Erythrocyte Transfusion; Oxygen; Mitochondria

Outcome Measures

Primary Outcomes (1)

• Variability of mitoPO2

  Variability of mitoPO2 before and after red cell transfusion. This will be compared to traditional parameters used to measure oxygenation and oxygen balance.

  Variability of mitoPO2 will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study

Secondary Outcomes (5)

• 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

Study Arms (1)

ICU patients with anaemia

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.

Eligibility Criteria

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

Study Population

All adult patients admitted to the intensive care unit with a Hb below 6.3 mmol/l, with a central venous catheter in situ, who are planned to undergo a transfusion of red blood cells

You may qualify if:

• adult patient admitted to the ICU
• Hb below 6.3 mmol/l (10 g/dl)
• central venous catheter in situ
• red cell transfusion planned

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research: lead
• Leiden University Medical Center: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Erasmus Medical Center: collaborator

Study Sites (2)

Amsterdam Medical Center

Amsterdam, Amsterdam-Zuidoost, Noord-Holland, 1105 AZ, Netherlands

Location

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Publications (2)

• Baysan M, Hilderink B, van Manen L, Caram-Deelder C, Mik EG, Juffermans NP, van der Bom JG, Arbous MS. Mitochondrial oxygen tension in critically ill patients receiving red blood cell transfusions: a multicenter observational cohort study. Intensive Care Med Exp. 2024 Jul 8;12(1):61. doi: 10.1186/s40635-024-00646-3.

  PMID: 38976096 DERIVED

• Baysan M, Arbous MS, Mik EG, Juffermans NP, van der Bom JG. Study protocol and pilot results of an observational cohort study evaluating effect of red blood cell transfusion on oxygenation and mitochondrial oxygen tension in critically ill patients with anaemia: the INsufficient Oxygenation in the Intensive Care Unit (INOX ICU-2) study. BMJ Open. 2020 May 17;10(5):e036351. doi: 10.1136/bmjopen-2019-036351.

  PMID: 32423938 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be taken for measurement of: troponin, creatinine kinase, creatinine, hemoglobin, lactate, central venous oxygen saturation, arterial saturation, arterial oxygen tension, and venous oxygen tension. Remaining plasma will be frozen and stored for further evaulation

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Johanna G van der Bom, PhD, MD

  Leiden University Medical Center and Sanquin Research Leiden

  STUDY CHAIR

• M S Arbous, PhD, MD

  Leiden University Medical Center

  STUDY CHAIR

• M Baysan, MD

  Leiden University Medical Center and Sanquin Research Leiden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 27, 2017
• Study Start: May 16, 2017
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2022
• Last Updated: January 19, 2023

Record last verified: 2022-12

Locations

NL (2)