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
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Recent 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.
Study objective
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
Study design
single-center, randomized, investigator blinded prospective study.
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), another group will receive helium
3*5 min just before release of the aortic cross clamp (Postconditioning, PostC,
group 3) and an additional group will receive both regimens (pre and
postconditioning, PrePostC, group 4). One group of patients will serve as
untreated controls (CON, group 1), and a positive control group will receive
preconditioning with sevoflurane (3 * 5min) before aortic cross clamping
(anaesthetic preconditioning, APC, group 5) which is known to induce
cardioprotection (positive control group).
Intervention
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), another group will receive helium
3*5 min just before release of the aortic cross clamp (Postconditioning, PostC,
group 3) and an additional group will receive both regimens (pre and
postconditioning, PrePostC, group 4). One group of patients will serve as
untreated controls (CON, group 1), and a positive control group will receive
preconditioning with sevoflurane (3 * 5min) before aortic cross clamping
(anaesthetic preconditioning, APC, group 5) which is known to induce
cardioprotection (positive control group).
Study burden and risks
Patients will receive total intravenous anaesthesia according to standard
anaesthetic procedures. Helium (70% helium, 30% oxygen) will be administered to
patients in the preconditioning groups. There are, up to now, no reports that
helium has any relevant cardiovascular, pulmonary, allergic or other side
effects. A gas-mixture of helium with oxygen (Heliox) is already in clinical
use for patients with severe asthma or for children undergoing mechanical
ventilation.
Meibergdreef 9
1100 DD Amsterdam
NL
Meibergdreef 9
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Age: * 18 Years, Patients who have to undergo elective cardiac surgery (CABG without valve surgery), Written informed consent
Exclusion criteria
Age * 18 years, Emergency operations, Pregnancy, Severe COPD, Absent informed consent, SaO2 < 90% at room temperature, Presumed non cooperatives, Legal incapacity, Diabetes Mellitus, Renal failure, liver failure, Combined valve and coronary artery procedures,
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-000992-12-NL |
| CCMO | NL22099.018.08 |