Use of Remote Ischaemic Preconditioning in the Prevention of Contrast Induced Nephropathy

NCT02516072 | Completed

• 1 other identifier: CGH-RIPC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

With an increasingly ageing population the incidence of peripheral arterial disease (PAD) is rising. With approximately one quarter of all PAD patients ultimately progressing to Critical Limb Ischaemia (CLI), increased demands are being placed on vascular imaging to accurately assess stenotic lesions. Early infrainguinal lesions (i.e. TASC A \& B) can be treated with angioplasty+/- stenting and accurate assessment relies on the imaging gold standard of angiography. Patients with PAD often have concomitant co morbidities such as diabetes and chronic renal impairment placing them at increased risk of developing contrast induced nephropathy (CIN) when exposed to iodinated contrast media. High risk individuals with decreased eGFR \<60ml/min have a risk of between 20-30% of developing CIN. They have increased morbidity and mortality risks with a greater need for dialysis and prolonged in patient hospital stays. Ideally, the investigators should be searching for ways to decrease the incidence of CIN. Animal studies and more recently pilot human trials have shown that subjecting a remote vascular bed to a brief ischaemic stress, followed by a period of reperfusion; in what has been termed remote ischemic preconditioning (RIPC), may confer a protective benefit against the development of CIN. This study aims to determine if RIPC can protect against CIN in patients undergoing elective peripheral angiography for infrainguinal disease.

Conditions

Remote Ischaemic Preconditioning; Contrast Induced Nephropathy

Keywords

remote ischemic preconditioning

Outcome Measures

Primary Outcomes (1)

• Reduction in the prevalence of contrast medium-induced nephropathy

  Reduction is defined as an increase in the serum creatinine (serC) concentration of \>25% from the baseline value within the 72-hour period after primary angiography.

  At 24, 48 and 72 hours post procedure and 4-week post procedure

Secondary Outcomes (2)

• NGAL levels

  At 2, 24, 48 and 72 hours post procedure

• Cystatin C levels

  At 2, 24, 48 and 72 hours post procedure

Other Outcomes (3)

• Length of hospital stay

  4 weeks post procedure

• Need for dialysis

  4 weeks post procedure

• Mortality

  4 weeks post procedure

Study Arms (2)

Control

NO INTERVENTION

Patients will receive iv hydration prior to procedure dependent on classification of risk as per eGFR.

Remote Ischaemic preconditioning (RIPC)

EXPERIMENTAL

Patients will receive iv hydration prior to procedure dependent on classification of risk as per eGFR. Additionally, patients will receive RIPC; a blood pressure cuff will be placed around one arm of the patient, it will then be inflated to a pressure of 250mmHg for 5 minutes. The cuff will then be deflated and the arm allowed to reperfuse for 5 minutes. This will be repeated so that each patient receives a total of 3 ischaemia-reperfusion cycles immediately prior to the procedure.

Other: RIPC

Interventions

RIPC OTHER

IV hydration prior to procedure dependent on classification of risk as per eGFR + RIPC

Remote Ischaemic preconditioning (RIPC)

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective intra-arterial peripheral angiography/angioplasty;
• Patients \>21 years of age;
• Patients with CKD as evidenced by eGFR levels of 30ml/min \< eGFR \< 60ml/min (moderate risk) or eGFR levels of \>= 60ml/min (low risk).

You may not qualify if:

• Severe renal impairment eGFR \<30ml/min;
• Evidence of acute renal failure or patients on dialysis;
• History of previous CIN;
• Contraindication to volume replacement therapy;
• Pregnancy;
• Patients on glibenclamide or nicorandil (these medications may interfere with RIPC).

Sponsors & Collaborators

• Changi General Hospital: lead
• University College Hospital Galway: collaborator

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (1)

• Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.

  PMID: 36645250 DERIVED

Study Officials

• Tjun Yip Tang

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 5, 2015
• Study Start: January 1, 2015
• Primary Completion: December 30, 2016
• Study Completion: September 1, 2018
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

SG (1)