Remote Ischemic Preconditioning During Lower Limb Revascu... | NCT04016857

Studies
Remote Ischemic Preconditioning During Lower Limb Revascularization

NCT04016857

Sponsor

University of Messina

Status

Completed

Last Update Posted

Oct 4, 2021Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Ischemic Preconditioning
Acute Kidney Injury
Limb Ischemia

Interventions

RIPC
Control

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2018Actual

Primary Completion Date

Jan 15, 2019Actual

Completion Date

Jun 15, 2019Actual

First Submitted Date

Jul 8, 2019

First Submission Date that Met QC Criteria

Jul 8, 2019

First Posted Date

Jul 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2021

Last Update Posted Date

Oct 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to evaluate the role of remote ischemic preconditioning (RIPC) in preventing acute kidney injury after lower limb revascularization.

Remote ischemic preconditioning(RIPC) is a simple, cost-free and non invasive procedure (transient upper limb ischemia/reperfusion) that could provide organ protection (Heart, Brain and Kidney) following ischemia injuries.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RIPC Group	Experimental	Remote ischemic preconditioning	Procedure: RIPC
Control Group	Sham Comparator	Sham remote ischemic preconditioning	Procedure: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RIPC	Procedure	4 cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of arm cuff	RIPC Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AKI	the incidence of Acute Kidney Injury, defined as absolute rise of ≥ 0.3 mg/dL and/or a relative increase of 25% in serum creatinine compared to preoperative	72 Hours
AKI	the incidence of Acute Kidney Injury, defined as decrease of 35% in GFR compared to preoperative.	72 Hours

Secondary Outcomes

Measure	Description	Time Frame
AKI Risk Score	the incidence of Acute Kidney Injury, defined as increase od 0.3 in Aki risk score (TIMP-2 * IGFBP-7)	24 Hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for open limb revascularization

Exclusion Criteria:

Peripheral vascular disease affecting upper limbs
Chronic kidney disease in stage 4 or 5 (eGFR<30 ml/min/1,73m2)
Patients underwent contrast-enhanced radiological exams in the previous 7 days
Treatment with glibencamide or prostaglandins

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alberto Noto, MD, PhD	University of Messina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
A.O.U. G.Martino - University of Messina		Messina		98100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Triple

Masking Description

The RIPC procedure were performed in the ward before going to operating room, and this is blinded to Investigators and surgical case anesthesiologist

Who Masked

Care ProviderInvestigatorOutcomes Assessor