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van CCT (UK)

van CCT (UK)

Helium and organ protection during bypass surgery

- candidate number3064
- NTR NumberNTR1226
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mrt-2008
- Secondary IDs08/050 MEC
- Public TitleHelium and organ protection during bypass surgery
- Scientific TitleOrgan protection by noble gases C A clinical study to investigate Helium induced Pre- and Postconditioning in patients undergoing coronary artery bypass surgery
- hypothesisRecent experimental and clinical data showed that the noble gas helium protects against myocardial reperfusion injury in rabbits in vivo and induces late preconditioning in rat hearts. It has also been demonstrated that another noble gas, xenon, can protect from myocardial damage by postconditioning. Supported by this evidence we hypothesize that helium induces pre- and postconditioning in humans.
- Healt Condition(s) or Problem(s) studiedCoronary Artery Bypass Grafting (CABG), Helium, Organ protection
- Inclusion criteria1. Age > 18 Years
2. Patients who have to undergo elective cardiac surgery (CABG without valve surgery)
3. Written informed consent
- Exclusion criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2008
- planned closingdate1-apr-2010
- Target number of participants125
- InterventionsFirst 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 cross clamp (Postconditioning, PostC,)
Third group will receive both regimens (pre and postconditioning, PrePostC,).
Fourth group of patients will serve as untreated controls (CON,)
Fifth group will serve as positive controls, and receive preconditioning with sevoflurane (3 * 5min) before aortic cross clamping (anaesthetic preconditioning, APC,)
- Primary outcomeMain 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 outcomeSecondary 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
- TimepointsTissue samples for investigation of primary outcome will be taken during surgery, first and second sample will be taken during installation of cardiopulmonary bypass, third sample will be taken after weaning of cardiopulmonary bypass, when aorta cross clamp is taken off.
Bood samples for investigations of secondary outcomes will be taken at baseline (before surgery),4,12,24 and 48 hours after surgery.
Hemodynamic parameters will be obtained during surgery.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- PublicationsN/A
- Brief summaryThe 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. Primary endpoinst are detection of signalling pathway molecules (PKC-e, p38MAPK, ERK and HSP27) and secondary parameters include estimation of myocardial damage by measurement of cardiac enzymes.
- Main changes (audit trail)
- RECORD12-feb-2008 - 20-mei-2008

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