Dataset Information

Protocol of supra-visceral aortic ischemic preconditioning for open surgical repair of thoracoabdominal aortic aneurysm : The EPICATA study (Evaluation of the Efficacy of Ischemic PreConditioning on morbidity and mortality in open ThoracoAbdominal Aortic surgery).

ABSTRACT: BACKGROUND:Open surgical repair (OSR) for thoracoabdominal aortic aneurysms (TAA) is associated with a high pulmonary and renal morbidity rate. Ischemic preconditioning (IPC) is a mechanism of protection against the deleterious effects of ischemia-reperfusion. To our knowledge IPC has never been tested during OSR for TAA. METHODS:The primary objective of the study is to evaluate the efficacy of IPC during OSR for TAA with respect to acute kidney injury (AKI) according to KDIGO and pneumonia/prolonged ventilation-time during the first 8 postoperative days. The secondary objectives are to compare both arms with respect to cardiac complications within 48?h, renal and pulmonary complications within 21?days and mortality at 60?days. To assess the efficacy of IPC with respect to pulmonary and renal morbidity, a cox model for competing risks will be used. Assuming that the event occurs among 36% of the patients when no IPC is performed, the allocation of 55 patients to each arm should allow detecting a hazard ratio of at least 2.75 with a power of 80% when admitting 5% for an error of first kind. This means that 110 patients, enrolled in this multicenter study, may be randomised within 36?months of the first randomization. Randomization will be performed to allocate patients either to surgery with preconditioning before aortic cross clamping (Arm 1) or to surgery without preconditioning before aortic cross clamping (Arm 2). Randomization takes place during the intervention after intravenous injection of heparin, or after the start of femoral assistance. The procedure for IPC will be a supra-visceral thoracic aortic cross clamping for 5?min followed by an unclamping period of 5?min. This procedure will be repeated twice before starting thoracic aortic cross clamping needed to perform surgery. CONCLUSIONS:Our hypothesis is that ischemic preconditioning could reduce clinical morbidity and the incidence of lung damage associated with supra-visceral aortic clamping. TRIAL REGISTRATION:EPICATAStudy registered in ClinicalTrial.gov / number: NCT03718312 on Oct.24.2018 URL number.

SUBMITTER: Palmier M

PROVIDER: S-EPMC7457237 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Protocol of supra-visceral aortic ischemic preconditioning for open surgical repair of thoracoabdominal aortic aneurysm : The EPICATA study (Evaluation of the Efficacy of Ischemic PreConditioning on morbidity and mortality in open ThoracoAbdominal Aortic surgery).

Palmier Mickael M Bubenheim Mickael M Chiche Laurent L Chaufour Xavier X Koskas Fabien F Fadel Elie E Magnan Pierre Edouard PE Ducasse Eric E Chakfe Nabil N Steinmetz Eric E Dusseaux Marie Melody MM Ricco Jean Baptiste JB Plissonnier Didier D

BMC surgery 20200827 1

<h4>Background</h4>Open surgical repair (OSR) for thoracoabdominal aortic aneurysms (TAA) is associated with a high pulmonary and renal morbidity rate. Ischemic preconditioning (IPC) is a mechanism of protection against the deleterious effects of ischemia-reperfusion. To our knowledge IPC has never been tested during OSR for TAA.<h4>Methods</h4>The primary objective of the study is to evaluate the efficacy of IPC during OSR for TAA with respect to acute kidney injury (AKI) according to KDIGO and ...[more]

PMID: 32854681

Similar Datasets

Project description:BackgroundSpinal cord injury (SCI) is a rare but severe complication after open or endovascular repair of descending thoracic aneurysms (DTAs) or thoracoabdominal aortic aneurysms (TAAAs). This meta-analysis aims to provide a comprehensive assessment of SCI rates and factors associated with SCI.MethodsA systematic literature search was performed in September 2022 looking for studies on open and/or endovascular repair of DTA and/or TAAA published after 2018, to update the results of our previously published meta-analysis. The primary outcome was permanent SCI. Secondary outcomes were temporary SCI, 30-day and in-hospital mortality, follow-up mortality, postoperative stroke, and cerebrospinal fluid (CSF) drain-related complications. Data were pooled as proportions using inverse-variance weighting.ResultsA total of 239 studies (71 new studies and 168 from our previous meta-analysis) and 61,962 patients were included. The overall pooled rate of permanent SCI was 3.3% [95% confidence interval (CI), 2.9-3.8%]. Open repair was associated with a permanent SCI rate of 4.0% (95% CI, 3.3-4.8%), and endovascular repair was associated with a permanent SCI rate of 2.9% (95% CI, 2.4-3.5%). Permanent SCI was 2.0% (95% CI, 1.2-3.3%) after DTA repair, and 4.7% (95% CI, 3.9-5.6%) after TAAA repair; permanent SCI rate was 3.8% (95% CI, 2.9-5.0%) for Crawford extent I, 13.4% (95% CI, 9.0-19.5%) for extent II, 7.1% (95% CI, 5.7-8.9%) for extent III, 2.3% (95% CI, 1.6-3.5%) for extent IV, and 6.7% (95% CI, 1.7-23.1%) for extent V TAAA aneurysms. The pooled rate of CSF drain related complications was 1.9% (95% CI, 0.8-4.7%) for severe, 0.4% (95% CI, 0.0-4.0%) for moderate, and 1.8% (95% CI, 0.6-5.6%) for minor complications.ConclusionsPermanent SCI occurs after both endovascular and open DTA or TAAA repairs. Open repairs and TAAA repairs have higher risk of SCI compared with endovascular or DTA repairs. In particular, extent II aneurysms present the highest overall risk of SCI.

Dataset Information

Protocol of supra-visceral aortic ischemic preconditioning for open surgical repair of thoracoabdominal aortic aneurysm : The EPICATA study (Evaluation of the Efficacy of Ischemic PreConditioning on morbidity and mortality in open ThoracoAbdominal Aortic surgery).

Publications

Protocol of supra-visceral aortic ischemic preconditioning for open surgical repair of thoracoabdominal aortic aneurysm : The EPICATA study (Evaluation of the Efficacy of Ischemic PreConditioning on morbidity and mortality in open ThoracoAbdominal Aortic surgery).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets