HELMOX - a monocentric, porospective observational study to determine oxidation parameters when using a heart-lung machine during coronary artery bypass surgery

HELMOX - a monocentric, porospective observational study to determine oxidation parameters when using a heart-lung machine during coronary artery bypass surgery - HELMOX

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00032225

Enrollment

100

Registered

2024-08-05

Start date

2024-11-28

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I25.1

Interventions

Group 1: Patient with coronary artery bypass surgery using a heart-lung machine Group 2: Patient with coronary artery bypass surgery without using a heart-lung machine

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - informed consent

Exclusion criteria

Exclusion criteria: - additional surgical or interventional therapies

Design outcomes

Primary

Measure	Time frame
Inflammation (Central Laboratory) •Leukocytes •CRP •Interleukin-6 •TNF alpha •Fibrinogen Complement System •C3 and C4 (Central Laboratory) •C1 Inhibitor (Central Laboratory) Oxidation Parameters •ROS/RNS (Schleicher) •MDA (Central Laboratory) •Glutathione (GSH) (Ms. Hannibal) •Zinc (Central Laboratory) •Selenium (Central Laboratory) •Vitamin C (Clotten) Isolated determination of hydrogen peroxide (H2O2) Sampling Time Points With CPB (on-pump) Without CPB (off-pump, OPCAB) •24 hr pre-op • 24 hr pre-op •Before start of HLM • Before coronary incision •Post-HLM • After coronary revascularization •Post-op Day 1 • Post-op Day 1 •Post-op Day 5 • Post-op Day 5	—

Measure

Time frame

Inflammation (Central Laboratory) •Leukocytes •CRP •Interleukin-6 •TNF alpha •Fibrinogen Complement System •C3 and C4 (Central Laboratory) •C1 Inhibitor (Central Laboratory) Oxidation Parameters •ROS/RNS (Schleicher) •MDA (Central Laboratory) •Glutathione (GSH) (Ms. Hannibal) •Zinc (Central Laboratory) •Selenium (Central Laboratory) •Vitamin C (Clotten) Isolated determination of hydrogen peroxide (H2O2) Sampling Time Points With CPB (on-pump) Without CPB (off-pump, OPCAB) •24 hr pre-op • 24 hr pre-op •Before start of HLM • Before coronary incision •Post-HLM • After coronary revascularization •Post-op Day 1 • Post-op Day 1 •Post-op Day 5 • Post-op Day 5

—

Secondary

Measure	Time frame
Cellular response (e.g. lymphocytes, neutrophils, granulocytes, platelets, etc.) Humorous response Hemolysis parameters Hemodynamic parameters (e.g. catecholamine and volume requirements) Clinical Data • All routine data • ICU stay • HGC/Clinic or hospital stay • Complication rates: # atrial fibrillation # delirium # acute kidney failure # wound infections # others • Pre-, intra-, and postoperative bleeding amounts • Administration of erythrocyte concentrates (PRBs) • Administration of cell saver blood • Duration of cardiopulmonary bypass (CPB) usage • Duration of aortic clamping • Duration of surgery • Duration of intubation • Duration and type of catecholamine administration	—

Measure

Time frame

Cellular response (e.g. lymphocytes, neutrophils, granulocytes, platelets, etc.) Humorous response Hemolysis parameters Hemodynamic parameters (e.g. catecholamine and volume requirements) Clinical Data • All routine data • ICU stay • HGC/Clinic or hospital stay • Complication rates: # atrial fibrillation # delirium # acute kidney failure # wound infections # others • Pre-, intra-, and postoperative bleeding amounts • Administration of erythrocyte concentrates (PRBs) • Administration of cell saver blood • Duration of cardiopulmonary bypass (CPB) usage • Duration of aortic clamping • Duration of surgery • Duration of intubation • Duration and type of catecholamine administration

—

Countries

Germany

Contacts

Public ContactFriedhelm Beyersdorf

Universitätsklinikum Freiburg

friedhelm.beyersdorf@uniklinik-freiburg.de+49 761 270 28181

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026