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

Organ protection by noble gases * A clinical study to investigate Helium induced Pre- and Postconditioning in patients undergoing coronary artery bypass surgery. - Helium induced pre- and postconditioning in CABG patients. (HIPP-CABG)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31964

Enrollment

125

Registered

2008-02-27

Start date

2008-06-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

coronary artery bypass grafting

Interventions

Administering Helium as preconditioning or postconditioning treatment. One group of patients will receive 3 * 5 minutes of Helium just before aortic cross clamping (preconditioning, PreC, group 2),

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age: * 18 Years, Patients who have to undergo elective cardiac surgery (CABG without valve surgery), Written informed consent

Exclusion criteria

Exclusion criteria: Age * 18 years, Emergency operations, Pregnancy, Severe COPD, Absent informed consent, SaO2

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 against surgery induced tissue damage in 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 against surgery induced tissue damage in 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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)