Clinical trial NCT01741896: Can Remote Ischaemic Preconditioning Reduce Contrast Induced Nephropathy in Patients Receiving Contrast for Computed Tomography?
Official title: Can Remote Ischaemic Preconditioning Reduce Contrast Induced Nephropathy in Patients Receiving Contrast for Computed Tomography?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contrast Induced Nephropathy
Remote Ischaemic Preconditioning
Lead sponsor: Mid Western Regional Hospital, Ireland
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Change in eGFR in those undergoing CT with IV contrast
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: Mid Western Regional Hospital
Study officials:
References:
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.
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.
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.