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Completed

NCT Number: NCT01741896

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

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.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mid Western Regional Hospital

Limerick, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote ischaemic preconditioning

Procedure

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 outcomes

  1. Change in eGFR in those undergoing CT with IV contrast

    Time frame: 48 hours

    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.

Sponsors and collaborators

Lead sponsor

Mid Western Regional Hospital, Ireland

Other

Registry information

Acronym: CT RIPC CIN

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 5, 2012
Registry last updated
Sep 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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