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Can Remote Ischaemic Preconditioning Reduce Contrast Induced Nephropathy in Patients Receiving Contrast for Computed Tomography? (CT RIPC CIN)

Primary Purpose

Contrast Induced Nephropathy, Remote Ischaemic Preconditioning

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Remote ischaemic preconditioning
Sponsored by
Mid Western Regional Hospital, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast Induced Nephropathy

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Hospital inpatients undergoing contrast enhanced abdomino-pelvic CT scanning.

Exclusion Criteria:

  • Those with an allergy/hypersensitivity to the contrast solution
  • Those with a Cr of above 150μmol/dL on admission, as is a contraindication to IV contrast.
  • Patients who are not getting IV contrast
  • Any patients with a history of renal transplantation
  • Any patients with a history of previous acute kidney injury necessitating management by a nephrologist
  • Patients taking either a sulphonlurea or nicorandil.

Sites / Locations

  • Mid Western Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

RIPC

Control arm

Arm Description

Patients in the RIPC arm will undergo a period of upper limb ischaemic preconditioning before their contrast enhanced CT scan. The RIPC stimulus involves four cycles of ischaemia/reperfusion (5 minutes of blood pressure cuff induced upper limb ischaemia with 3 minutes reperfusion). This will start at a time of 30 - 40 minutes before the administration of contrast. The cuff is inflated to 15mmHg above systolic pressure at each inflation.

Patients in the control arm will undergo no extra intervention.

Outcomes

Primary Outcome Measures

Change in eGFR in those undergoing CT with IV contrast
The study aims to define the effectiveness in the nephroprotective properties of remote ischaemic preconditioning. The outcome measures are the eGFR at 24 and 48 hours post infusion of IV contrast compared to preinfusion levels, in groups randomised into either undergoing RIPC or a control group.

Secondary Outcome Measures

Full Information

First Posted
December 4, 2012
Last Updated
September 12, 2013
Sponsor
Mid Western Regional Hospital, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT01741896
Brief Title
Can Remote Ischaemic Preconditioning Reduce Contrast Induced Nephropathy in Patients Receiving Contrast for Computed Tomography?
Acronym
CT RIPC CIN
Official Title
Can Remote Ischaemic Preconditioning Reduce Contrast Induced Nephropathy in Patients Receiving Contrast for Computed Tomography?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mid Western Regional Hospital, Ireland

4. Oversight

5. Study Description

Brief Summary
Computated tomography (CT) is an invaluable medical resource for both physicians and surgeons. Contrast media are an aid to improve the diagnostic yield of CT. While an incredibly powerful means of imaging the human body, there are possible complications to the use of contrast including a hypersensitive response and contract induced nephropathy (CIN). The latter will typically occur 48-72 hours after administration. One recent meta - analysis of serum creatinine levels following contrast enhanced CT found 6.4% of those undergoing this investigation developed CIN. Although typically transient, 1 % had a persisting reduced renal function, with a small minority needing renal replacement therapy (RRT). The development of CIN was influenced by co morbidities and by the amount of contrast given. The mechanism of injury to the kidney is not definitively established, but is thought most likely due to hypoxia resulting from reduced blood flow, thereby giving rise to oxygen free radicals causing direct damage to the kidney and also direct tubular damage. Remote conditioning ischaemia has been hypothesized to be nephroprotective, whereby induced transient ischaemia at another site could buffer the impact of the contrast medium's effects. This was first demonstrated during cardiac angiograms, with those patients whom received multiple balloon inflations in the coronary arteries were found to have a lower incidence of CIN than those with fewer balloon inflations. Thus it could be hypothesised that any ischaemia temporarily induced could be nephroprotective. This can be at a point of extremity, rather than involving central organs, such as the arm, with ischaemia induced by the use of a blood pressure cuff, inflated to above systolic blood pressure levels. No studies have been found in the literature attempting to demonstrate this effect in relation to contrast CT studies. Consequently, a randomised control clinical trial of patients to assess the effectiveness of remote ischaemic preconditioning is proposed. Study Hypothesis: That performing remote ischaemic preconditioning on those undergoing CTs involving IV contrast is nephroprotective.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy, Remote Ischaemic Preconditioning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIPC
Arm Type
Active Comparator
Arm Description
Patients in the RIPC arm will undergo a period of upper limb ischaemic preconditioning before their contrast enhanced CT scan. The RIPC stimulus involves four cycles of ischaemia/reperfusion (5 minutes of blood pressure cuff induced upper limb ischaemia with 3 minutes reperfusion). This will start at a time of 30 - 40 minutes before the administration of contrast. The cuff is inflated to 15mmHg above systolic pressure at each inflation.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Patients in the control arm will undergo no extra intervention.
Intervention Type
Procedure
Intervention Name(s)
Remote ischaemic preconditioning
Intervention Description
The intervention is 4 cycles of upper limb ischaemic preconditioning. Each cycle consists of 5 minutes of blood pressure cuff induced ischaemia with 3 minutes of reperfusion. The ischaemic stimulus is induced by inflation of the cuff to 15mmHg above systolic pressure. The reperfusion stimulus is induced by cuff deflation. The RIPC stimulus is commenced at between 30-40 minutes prior to the administration of the IV contrast.
Primary Outcome Measure Information:
Title
Change in eGFR in those undergoing CT with IV contrast
Description
The study aims to define the effectiveness in the nephroprotective properties of remote ischaemic preconditioning. The outcome measures are the eGFR at 24 and 48 hours post infusion of IV contrast compared to preinfusion levels, in groups randomised into either undergoing RIPC or a control group.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hospital inpatients undergoing contrast enhanced abdomino-pelvic CT scanning. Exclusion Criteria: Those with an allergy/hypersensitivity to the contrast solution Those with a Cr of above 150μmol/dL on admission, as is a contraindication to IV contrast. Patients who are not getting IV contrast Any patients with a history of renal transplantation Any patients with a history of previous acute kidney injury necessitating management by a nephrologist Patients taking either a sulphonlurea or nicorandil.
Facility Information:
Facility Name
Mid Western Regional Hospital
City
Limerick
ZIP/Postal Code
Limerick
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18829224
Citation
Walsh SR, Tang TY, Sadat U, Gaunt ME. Remote ischemic preconditioning in major vascular surgery. J Vasc Surg. 2009 Jan;49(1):240-3. doi: 10.1016/j.jvs.2008.07.051. Epub 2008 Oct 1.
Results Reference
background
PubMed Identifier
21952203
Citation
Whittaker P, Przyklenk K. Remote-conditioning ischemia provides a potential approach to mitigate contrast medium-induced reduction in kidney function: a retrospective observational cohort study. Cardiology. 2011;119(3):145-50. doi: 10.1159/000330930. Epub 2011 Sep 23.
Results Reference
background
PubMed Identifier
26026638
Citation
Healy DA, Feeley I, Keogh CJ, Scanlon TG, Hodnett PA, Stack AG, Clarke Moloney M, Whittaker P, Walsh SR. Remote ischemic conditioning and renal function after contrast-enhanced CT scan: A randomized trial. Clin Invest Med. 2015 May 31;38(3):E110-8. doi: 10.25011/cim.v38i3.22706.
Results Reference
derived

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Can Remote Ischaemic Preconditioning Reduce Contrast Induced Nephropathy in Patients Receiving Contrast for Computed Tomography?

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