Cargando…

Effect of remote ischaemic conditioning on contrast-induced nephropathy in patients undergoing elective coronary angiography (ERICCIN): rationale and study design of a randomised single-centre, double-blind placebo-controlled trial

BACKGROUND: Contrast-induced nephropathy (CIN), an acute kidney injury resulting from the administration of intravascular iodinated contrast media, is an important cause of morbidity/mortality following coronary angiographic procedures in high-risk patients. Despite preventative measures intended to...

Descripción completa

Detalles Bibliográficos
Autores principales: Bell, Robert M., Rear, Roger, Cunningham, John, Dawnay, Anne, Yellon, Derek M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3937541/
https://www.ncbi.nlm.nih.gov/pubmed/24292557
http://dx.doi.org/10.1007/s00392-013-0637-3
_version_ 1782305514354376704
author Bell, Robert M.
Rear, Roger
Cunningham, John
Dawnay, Anne
Yellon, Derek M.
author_facet Bell, Robert M.
Rear, Roger
Cunningham, John
Dawnay, Anne
Yellon, Derek M.
author_sort Bell, Robert M.
collection PubMed
description BACKGROUND: Contrast-induced nephropathy (CIN), an acute kidney injury resulting from the administration of intravascular iodinated contrast media, is an important cause of morbidity/mortality following coronary angiographic procedures in high-risk patients. Despite preventative measures intended to mitigate the risk of CIN, there remains a need for an effective intervention. Remote ischaemic conditioning (RIC), where non-injurious ischaemia is applied to an arm prior to the administration of contrast, has shown promise in attenuating CIN but its effectiveness in preserving long-term renal function is unknown, which will be studied as part of the effect of remote ischaemic conditioning against contrast-induced nephropathy (ERICCIN) trial. (http://Controlled-trials.com Identifier: ISRCTN49645414.) METHODS: The ERICCIN trial is a single-centre, randomised double-blinded placebo-controlled trial which plans to recruit 362 patients who are at risk of CIN, defined by pre-existent renal impairment (estimated glomerular filtration rate <60 ml/min/1.73 m(2)), over a period of 2 years. Patients will be randomised to either control or RIC consisting of 4, 5 min 200 mmHg balloon-cuff inflation/deflations, to the upper arm. The primary endpoint will be the development of CIN (>25 % of eGFR, or rise of creatinine of >44 μmol/l) at 48 h. A key secondary endpoint will be whether RIC impacts upon persistent renal impairment over the 3-month follow-up period. Additional secondary endpoints include the measurement of serum neutrophil gelatinase-associated lipocalin and urinary albumin at 6, 48 h and 3 months following administration of contrast. IMPLICATIONS: Findings from ERICCIN trial will potentially demonstrate that RIC attenuates contrast-induced acute and chronic kidney injury and influence future clinical practice guidelines in at-risk patients undergoing coronary angiographic procedures.
format Online
Article
Text
id pubmed-3937541
institution National Center for Biotechnology Information
language English
publishDate 2013
publisher Springer Berlin Heidelberg
record_format MEDLINE/PubMed
spelling pubmed-39375412014-03-06 Effect of remote ischaemic conditioning on contrast-induced nephropathy in patients undergoing elective coronary angiography (ERICCIN): rationale and study design of a randomised single-centre, double-blind placebo-controlled trial Bell, Robert M. Rear, Roger Cunningham, John Dawnay, Anne Yellon, Derek M. Clin Res Cardiol Original Paper BACKGROUND: Contrast-induced nephropathy (CIN), an acute kidney injury resulting from the administration of intravascular iodinated contrast media, is an important cause of morbidity/mortality following coronary angiographic procedures in high-risk patients. Despite preventative measures intended to mitigate the risk of CIN, there remains a need for an effective intervention. Remote ischaemic conditioning (RIC), where non-injurious ischaemia is applied to an arm prior to the administration of contrast, has shown promise in attenuating CIN but its effectiveness in preserving long-term renal function is unknown, which will be studied as part of the effect of remote ischaemic conditioning against contrast-induced nephropathy (ERICCIN) trial. (http://Controlled-trials.com Identifier: ISRCTN49645414.) METHODS: The ERICCIN trial is a single-centre, randomised double-blinded placebo-controlled trial which plans to recruit 362 patients who are at risk of CIN, defined by pre-existent renal impairment (estimated glomerular filtration rate <60 ml/min/1.73 m(2)), over a period of 2 years. Patients will be randomised to either control or RIC consisting of 4, 5 min 200 mmHg balloon-cuff inflation/deflations, to the upper arm. The primary endpoint will be the development of CIN (>25 % of eGFR, or rise of creatinine of >44 μmol/l) at 48 h. A key secondary endpoint will be whether RIC impacts upon persistent renal impairment over the 3-month follow-up period. Additional secondary endpoints include the measurement of serum neutrophil gelatinase-associated lipocalin and urinary albumin at 6, 48 h and 3 months following administration of contrast. IMPLICATIONS: Findings from ERICCIN trial will potentially demonstrate that RIC attenuates contrast-induced acute and chronic kidney injury and influence future clinical practice guidelines in at-risk patients undergoing coronary angiographic procedures. Springer Berlin Heidelberg 2013-11-29 2014 /pmc/articles/PMC3937541/ /pubmed/24292557 http://dx.doi.org/10.1007/s00392-013-0637-3 Text en © The Author(s) 2013 https://creativecommons.org/licenses/by/2.0/ Open AccessThis article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Paper
Bell, Robert M.
Rear, Roger
Cunningham, John
Dawnay, Anne
Yellon, Derek M.
Effect of remote ischaemic conditioning on contrast-induced nephropathy in patients undergoing elective coronary angiography (ERICCIN): rationale and study design of a randomised single-centre, double-blind placebo-controlled trial
title Effect of remote ischaemic conditioning on contrast-induced nephropathy in patients undergoing elective coronary angiography (ERICCIN): rationale and study design of a randomised single-centre, double-blind placebo-controlled trial
title_full Effect of remote ischaemic conditioning on contrast-induced nephropathy in patients undergoing elective coronary angiography (ERICCIN): rationale and study design of a randomised single-centre, double-blind placebo-controlled trial
title_fullStr Effect of remote ischaemic conditioning on contrast-induced nephropathy in patients undergoing elective coronary angiography (ERICCIN): rationale and study design of a randomised single-centre, double-blind placebo-controlled trial
title_full_unstemmed Effect of remote ischaemic conditioning on contrast-induced nephropathy in patients undergoing elective coronary angiography (ERICCIN): rationale and study design of a randomised single-centre, double-blind placebo-controlled trial
title_short Effect of remote ischaemic conditioning on contrast-induced nephropathy in patients undergoing elective coronary angiography (ERICCIN): rationale and study design of a randomised single-centre, double-blind placebo-controlled trial
title_sort effect of remote ischaemic conditioning on contrast-induced nephropathy in patients undergoing elective coronary angiography (ericcin): rationale and study design of a randomised single-centre, double-blind placebo-controlled trial
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3937541/
https://www.ncbi.nlm.nih.gov/pubmed/24292557
http://dx.doi.org/10.1007/s00392-013-0637-3
work_keys_str_mv AT bellrobertm effectofremoteischaemicconditioningoncontrastinducednephropathyinpatientsundergoingelectivecoronaryangiographyericcinrationaleandstudydesignofarandomisedsinglecentredoubleblindplacebocontrolledtrial
AT rearroger effectofremoteischaemicconditioningoncontrastinducednephropathyinpatientsundergoingelectivecoronaryangiographyericcinrationaleandstudydesignofarandomisedsinglecentredoubleblindplacebocontrolledtrial
AT cunninghamjohn effectofremoteischaemicconditioningoncontrastinducednephropathyinpatientsundergoingelectivecoronaryangiographyericcinrationaleandstudydesignofarandomisedsinglecentredoubleblindplacebocontrolledtrial
AT dawnayanne effectofremoteischaemicconditioningoncontrastinducednephropathyinpatientsundergoingelectivecoronaryangiographyericcinrationaleandstudydesignofarandomisedsinglecentredoubleblindplacebocontrolledtrial
AT yellonderekm effectofremoteischaemicconditioningoncontrastinducednephropathyinpatientsundergoingelectivecoronaryangiographyericcinrationaleandstudydesignofarandomisedsinglecentredoubleblindplacebocontrolledtrial