NCT03723993

Brief Summary

The objective of study is to detect effect of remote ischemic preconditioning on serum lactate levels during and after cardiac surgery with cardiopulmonary bypass in addition to its effect on cardiac and renal clinical outcomes.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

October 26, 2018

Last Update Submit

February 1, 2021

Conditions

Lactic Acidosis

Keywords

Ischemic preconditioningLactate levelCardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

  • Serum lactate level

    mmol/l from arterial blood gas sample

    1 minute at the end of operation

Secondary Outcomes (65)

  • Serum lactate level

    3 minutes after induction of anesthesia

  • Serum lactate level

    30 minutes, after cardiopulmonary bypass

  • Serum lactate level

    1 minute before cardiopulmonary bypass

  • Serum lactate level

    24 hours postoperatively.

  • Serum lactate level

    48 hours postoperatively.

  • +60 more secondary outcomes

Other Outcomes (1)

  • Age

    1 hour before operation once the patient is recruited

Study Arms (2)

Control group

PLACEBO COMPARATOR

control group will have non inflated cuff around the arm.

Device: Non inflated cuff

RIPC group

ACTIVE COMPARATOR

Inflated cuff will be done systematically and regularly

Device: Inflated cuff

Interventions

Inflated cuffDEVICE

After patient being draped, applying cuff inflation will be done to the upper arm not having the arterial line inserted of about 200 mmHg or 15 mmHg above patient's systolic pressure 3 cycles 5 minutes each followed by 5 minutes of pressure relieve

RIPC group
Non inflated cuffDEVICE

non inflated cuff around the arm for the control group

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years of age or older
  • Elective cardiovascular surgery requiring cardiopulmonary bypass either for CABG or valve replacement.

You may not qualify if:

  • Patients with emergency surgeries.
  • Off pump heart surgery.
  • Hepatic affection (INR\>2).
  • Renal affection (creatinine \>1.6 mg/dl for men and \>1.4 mg/dl for women).
  • Peripheral vascular disease affecting upper limbs.
  • Patients taking the antidiabetic sulphonylurea glyburide ( glibenclamide) or receiving nicorandil drug therapy will be excluded because these agents have been shown to abolish preconditioning.
  • Patients being considered for radial artery conduit harvesting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Hamed

Al Fayyum, 63511, Egypt

Location

Related Publications (4)

  • Saxena P, Newman MA, Shehatha JS, Redington AN, Konstantinov IE. Remote ischemic conditioning: evolution of the concept, mechanisms, and clinical application. J Card Surg. 2010 Jan-Feb;25(1):127-34. doi: 10.1111/j.1540-8191.2009.00820.x. Epub 2009 Jun 22.

    PMID: 19549044BACKGROUND

  • Heusch G. Cardioprotection: chances and challenges of its translation to the clinic. Lancet. 2013 Jan 12;381(9861):166-75. doi: 10.1016/S0140-6736(12)60916-7. Epub 2012 Oct 22.

    PMID: 23095318BACKGROUND

  • Thielmann M, Kottenberg E, Kleinbongard P, Wendt D, Gedik N, Pasa S, Price V, Tsagakis K, Neuhauser M, Peters J, Jakob H, Heusch G. Cardioprotective and prognostic effects of remote ischaemic preconditioning in patients undergoing coronary artery bypass surgery: a single-centre randomised, double-blind, controlled trial. Lancet. 2013 Aug 17;382(9892):597-604. doi: 10.1016/S0140-6736(13)61450-6.

    PMID: 23953384BACKGROUND

  • Badreldin AM, Doerr F, Elsobky S, Brehm BR, Abul-dahab M, Lehmann T, Bayer O, Wahlers T, Hekmat K. Mortality prediction after cardiac surgery: blood lactate is indispensible. Thorac Cardiovasc Surg. 2013 Dec;61(8):708-17. doi: 10.1055/s-0032-1324796. Epub 2013 Mar 11.

    PMID: 24338631BACKGROUND

MeSH Terms

Conditions

Acidosis, Lactic

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mohamed A Hamed, MD

    Faculty of medicine, Fayoum University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia

Study Record Dates

First Submitted

October 26, 2018

First Posted

October 30, 2018

Study Start

January 15, 2018

Primary Completion

November 15, 2018

Study Completion

December 15, 2018

Last Updated

February 3, 2021

Record last verified: 2021-02

Locations

EG(1)