NCT03238391

Brief Summary

The purpose of this study is to demonstrate the effectiveness of ischemic preconditioning in the emergency department to prevent contrast induced nephropathy

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

July 31, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2018

Completed
Last Updated

August 3, 2017

Status Verified

July 1, 2017

Enrollment Period

6 months

First QC Date

July 31, 2017

Last Update Submit

July 31, 2017

Conditions

Contrast-induced Nephropathy

Keywords

Contrast-induced nephropathyIschemic preconditioning

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants developing contrast-induced nephropathy

    %25 increase or a greater than 0,5 mg/dl increase in the serum creatinine level, 48 to 72 hours after the administration of contrast agent compared with the baseline creatinine measurement

    48 to 72 hours

Secondary Outcomes (1)

  • renal replacement theraphy

    1 month

Study Arms (2)

Study group

EXPERIMENTAL

Patients will receive ischemia and reperfusion of the arm by inflating a blood pressure cuff around the arm at 50 mmHg above the systolic blood pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three times

Procedure: Ischemic preconditioning

Sham group

SHAM COMPARATOR

Patients will receive ischemia and reperfusion of the arm by inflating a blood pressure cuff around the arm at 10 mmHg below the diastolic blood pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three times

Procedure: Ischemic preconditioning

Interventions

Ischemic preconditioningPROCEDURE

It is mentioned before in arm/group descriptions

Sham groupStudy group

Eligibility Criteria

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

You may qualify if:

  • Participants, older than 18 years old and received contrast enhanced CT scan in the emergency medicine department
  • The Mehran Risk Score is greater than 5 points

You may not qualify if:

  • The Mehran Risk Score is under 6 points
  • Participants who doesn't want to enroll the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Habeb M, Agac MT, Aliyev F, Pehlivanoglu S, Ongen Z. [Contrast media-induced nephropathy: clinical burden and current attempts for prevention]. Anadolu Kardiyol Derg. 2005 Jun;5(2):124-9. Turkish.

    PMID: 15939688BACKGROUND

  • McCullough PA, Choi JP, Feghali GA, Schussler JM, Stoler RM, Vallabahn RC, Mehta A. Contrast-Induced Acute Kidney Injury. J Am Coll Cardiol. 2016 Sep 27;68(13):1465-1473. doi: 10.1016/j.jacc.2016.05.099.

    PMID: 27659469BACKGROUND

  • Kelly AM, Dwamena B, Cronin P, Bernstein SJ, Carlos RC. Meta-analysis: effectiveness of drugs for preventing contrast-induced nephropathy. Ann Intern Med. 2008 Feb 19;148(4):284-94. doi: 10.7326/0003-4819-148-4-200802190-00007.

    PMID: 18283206BACKGROUND

  • Marenzi G, Bartorelli AL. Recent advances in the prevention of radiocontrast-induced nephropathy. Curr Opin Crit Care. 2004 Dec;10(6):505-9. doi: 10.1097/01.ccx.0000145098.13199.e8.

    PMID: 15616393BACKGROUND

  • Barreto R. Prevention of contrast-induced nephropathy: the rational use of sodium bicarbonate. Nephrol Nurs J. 2007 Jul-Aug;34(4):417-21.

    PMID: 17891910BACKGROUND

  • Asif A, Garces G, Preston RA, Roth D. Current trials of interventions to prevent radiocontrast-induced nephropathy. Am J Ther. 2005 Mar-Apr;12(2):127-32. doi: 10.1097/01.mjt.0000143694.60662.11.

    PMID: 15767830BACKGROUND

  • Ozcan EE, Guneri S, Akdeniz B, Akyildiz IZ, Senaslan O, Baris N, Aslan O, Badak O. Sodium bicarbonate, N-acetylcysteine, and saline for prevention of radiocontrast-induced nephropathy. A comparison of 3 regimens for protecting contrast-induced nephropathy in patients undergoing coronary procedures. A single-center prospective controlled trial. Am Heart J. 2007 Sep;154(3):539-44. doi: 10.1016/j.ahj.2007.05.012.

    PMID: 17719303BACKGROUND

  • Cheung MM, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, Holtby HM, Cox PN, Smallhorn JF, Van Arsdell GS, Redington AN. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery: first clinical application in humans. J Am Coll Cardiol. 2006 Jun 6;47(11):2277-82. doi: 10.1016/j.jacc.2006.01.066. Epub 2006 May 15.

    PMID: 16750696BACKGROUND

  • Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.

    PMID: 17707752BACKGROUND

  • Kharbanda RK, Li J, Konstantinov IE, Cheung MM, White PA, Frndova H, Stokoe J, Cox P, Vogel M, Van Arsdell G, MacAllister R, Redington AN. Remote ischaemic preconditioning protects against cardiopulmonary bypass-induced tissue injury: a preclinical study. Heart. 2006 Oct;92(10):1506-11. doi: 10.1136/hrt.2004.042366. Epub 2006 Jul 3.

    PMID: 16818489BACKGROUND

  • Ali ZA, Callaghan CJ, Lim E, Ali AA, Nouraei SA, Akthar AM, Boyle JR, Varty K, Kharbanda RK, Dutka DP, Gaunt ME. Remote ischemic preconditioning reduces myocardial and renal injury after elective abdominal aortic aneurysm repair: a randomized controlled trial. Circulation. 2007 Sep 11;116(11 Suppl):I98-105. doi: 10.1161/circulationaha.106.679167.

    PMID: 17846333BACKGROUND

  • Venugopal V, Laing CM, Ludman A, Yellon DM, Hausenloy D. Effect of remote ischemic preconditioning on acute kidney injury in nondiabetic patients undergoing coronary artery bypass graft surgery: a secondary analysis of 2 small randomized trials. Am J Kidney Dis. 2010 Dec;56(6):1043-9. doi: 10.1053/j.ajkd.2010.07.014. Epub 2010 Oct 25.

    PMID: 20974511BACKGROUND

MeSH Terms

Interventions

Ischemic Preconditioning

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Central Study Contacts

Yavuz Yigit, Specialist

CONTACT

+90 505 6628344dryavuzyigit@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency medicine specialist

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 3, 2017

Study Start

August 15, 2017

Primary Completion

February 15, 2018

Study Completion

February 15, 2018

Last Updated

August 3, 2017

Record last verified: 2017-07