Helium and organ protection during bypass surgery

Organ protection by noble gases ¨C A clinical study to investigate Helium induced Pre- and Postconditioning in patients undergoing coronary artery bypass surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25552

Enrollment

125

Registered

2008-03-17

Start date

2008-04-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

The aim of this clinical study is to investigate whether the non-anaesthetic noble gas helium induces preconditioning (PreC) and postconditioning (PostC) in patients undergoing coronary artery bypass graft (CABG) surgery.

Interventions

First group of patients will receive 3 * 5 minutes of Helium just before aortic cross clamping (preconditioning, PreC,) second group will receive helium 3*5 min just before release of the aortic cro

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 Years 2. Patients who have to undergo elective cardiac surgery (CABG without valve surgery) 3. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Age < 18 years 2.Emergency operations 3. Pregnancy 4. Severe COPD 5. Absent informed consent 6. SaO2 < 90% at room temperature 7. Presumed non cooperatives 8. Legal incapacity 9. Diabetes Mellitus 10. Renal failure 11. Comined procedures

Design outcomes

Primary

Measure	Time frame
Main study parameters are detection of signalling pathway molecules involved in anaesthetic preconditioning (PKC-e, p38MAPK, ERK and HSP27). This will be done by molecular analysis of myocardial tissue samples in our laboratory.	—

Secondary

Measure	Time frame
Secondary parameters are cardiac enzyme release after surgery (troponine T, CPK, CK-MB) and haemodynamics during surgery measured by transoesophageal echocardiography (TEE). Furthermore, several biomarkers will be investigated to see whether helium has a protective effect from surgery induced tissue on other organs; urine N-acetyl-glucosaminase (NAG) to estimate kidney damage, Intestinal-type fatty acid binding protein (I-FABP)/liver-type fatty acid binding protein (L-FABP)/ heart-type fatty acid binding protein (H-FABP) to estimate intestinal injury, and ¨¢-glutathione S-transferase (¨¢-GST) to estimate liver damage	—

Measure

Time frame

Secondary parameters are cardiac enzyme release after surgery (troponine T, CPK, CK-MB) and haemodynamics during surgery measured by transoesophageal echocardiography (TEE). Furthermore, several biomarkers will be investigated to see whether helium has a protective effect from surgery induced tissue on other organs; urine N-acetyl-glucosaminase (NAG) to estimate kidney damage, Intestinal-type fatty acid binding protein (I-FABP)/liver-type fatty acid binding protein (L-FABP)/ heart-type fatty acid binding protein (H-FABP) to estimate intestinal injury, and ¨¢-glutathione S-transferase (¨¢-GST) to estimate liver damage

—

Contacts

Public ContactB. Preckel

Department of Anesthesiology, Academic Medical Center University of Amsterdam, Meibergdreef 9 Postbus 22660 H1Z-120

b.preckel@amc.uva.nl+31 20 5662162,

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)