Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)

Mortality Clinical Trial

Official title:

Remote Ischaemic Preconditioning for Heart Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01067703
• Other study ID #: ME 3559/1-1
• Status: Terminated
• Phase: Phase 3
• First received: February 10, 2010
• Last updated: December 1, 2015
• Start date: December 2010
• Est. completion date: May 2015

Study information

• Verified date: September 2014
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury in patients undergoing cardiac surgery compared to control intervention.

Description:

Cardiac surgery with cardiopulmonary bypass is associated with a predictable incidence of myocardial, neurological and renal dysfunction. This significant morbidity and mortality is at least partly due to perioperative ischaemia. Remote ischaemic preconditioning (RIPC) is a novel, simple, non-invasive and inexpensive intervention by which ischaemia of non-vital tissue (skeletal muscles) protects remote organs (heart, brain and kidney) from a subsequent sustained episode of ischaemia. The investigators perform a multicenter randomized controlled study to evaluate that RIPC reduces teh severity of perioperative ischaemic injury in patients undergoing cardiac surgery, and results in about 1/3 risk reduction in the occurence of major adverse events.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1400
• Est. completion date: May 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients undergoing heart surgery on cardiopulmonary bypass

Exclusion Criteria:

• age < 18

• Emergency cases

• left ventricular ejection fraction less than 30%

• current atrial fibrillation

• Inability to give informed consent

• preoperative use of inotropics or mechanical assist device

• severe liver, renal and pulmonary disease

• recent myocardial infarction (within 7 days)

• recent systemic infection or sepsis (within 7 days)

• severe stroke (within 2 months)

• peripheral vascular disease affecting upper limbs

• previous serious psychiatric disorders (e.g. schizophrenia, dementia)

• concomitant carotid endarterectomy

• rare surgeries: cardiac transplantation, correction of complicated congenital anomalies, pulmonary thromboembolectomy, off-pump surgery, minimal-invasive operation without sternotomy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mortality
• Myocardial Injury

Intervention

Procedure:
• Remote Ischemic Preconditioning
RIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200 mm Hg, whereas the pressure has to be at least 20 mm Hg greater than the systolic arterial pressure measured via the arterial line.
• Control/sham procedure (blood pressure cuff)
Sham placement of the blood pressure cuff around a dummy arm inflated to a pressure of 200 mm Hg with four cycles of 5 min inflation and 5 min deflation.

Locations

Country	Name	City	State
Germany	University Hospital Aachen (RWTH)	Aachen
Germany	University Hospital Charite	Berlin
Germany	University Hospital Bonn	Bonn
Germany	University Hospital Frankfurt/M	Frankfurt/M
Germany	University Hospital Goettingen	Goettingen
Germany	University Hospital Schleswig-Holstein	Kiel
Germany	University Hospital of Schleswig-Holstein	Luebeck
Germany	University Hospital Magdeburg	Magdeburg
Germany	University Hospital Rostock	Rostock
Germany	University Hospital Wuerzburg	Wuerzburg

Sponsors (3)

Lead Sponsor	Collaborator
University of Schleswig-Holstein	German Research Foundation, University Hospital, Frankfurt

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Meybohm P, Bein B, Brosteanu O, Cremer J, Gruenewald M, Stoppe C, Coburn M, Schaelte G, Böning A, Niemann B, Roesner J, Kletzin F, Strouhal U, Reyher C, Laufenberg-Feldmann R, Ferner M, Brandes IF, Bauer M, Stehr SN, Kortgen A, Wittmann M, Baumgarten G, M — View Citation

Meybohm P, Zacharowski K, Cremer J, Roesner J, Kletzin F, Schaelte G, Felzen M, Strouhal U, Reyher C, Heringlake M, Schön J, Brandes I, Bauer M, Knuefermann P, Wittmann M, Hachenberg T, Schilling T, Smul T, Maisch S, Sander M, Moormann T, Boening A, Weiga — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure	Time frame until hospital discharge	In-hospital	No
Secondary	Occurence of any component of the composite outcome		Postoperative hospital discharge, 3 months, 12 months	No
Secondary	length of stay on the intensive care unit		Postoperative during hospital stay	No
Secondary	total hospital stay		hospital discharge	No
Secondary	new onset of atrial fibrillation		In-hospital	No
Secondary	Delirium		Postoperative 24, 48, 72, 96 hrs	No