Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05350683
Other study ID # VascularInvestigationNSEACV
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 1, 2017
Est. completion date May 20, 2020

Study information

Verified date April 2022
Source Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction: Contrast induced nephropathy (CIN) is a major inconvenience in the use of iodinated contrast media (ICM) and it is associated with a significant increase in morbimortality and cost of hospitalization. Remote ischemic preconditioning (RIPC) is a non-invasive and cost-effective tissular protection technique that has proven beneficial in decreasing renal insult in patients receiving intravascular contrast. Aim: The primary outcome of this study is to evaluate the impact of RIPC on the incidence of CIN in patients undergoing endovascular aneurysm repair.Material and Methods: Patients suffering from aortic aneurysm were recruited prior to the administration of iodinated contrast media. Randomization was used to assign patients into the control/RIPC groups. Biochemical parameters determined renal function before and after surgery in immediate (24-72 hours) and at 30 days' follow-up.


Description:

2.1. VARIABLES ANALYZED A randomized prospective study of patients undergoing endovascular treatment for infrarenal abdominal aortic aneurysm, thoracoabdominal aortic aneurysm, descending aortic aneurysm and aneurysms of the aortoiliac sector was designed. These patients were operated at the University Clinical Hospital of Valladolid, in the period between January 2017 and January 2019. The study, which received no financial support from the industry, was performed in agreement with the Declaration of Helsinki and was approved by the institutional review board at each participating site (PI 20-1745, Valladolid East Ethics Committee for Clinical Investigation). In accordance with institutional and local regulatory policies, all patients who underwent procedures within this study signed an informed written consent. This study only included patients scheduled for elective aortic surgery treated by endovascular repair. On the other hand, exclusion criteria were applied in patients who had peripheral artery disease in the upper limbs, chronic kidney disease grade V on replacement therapy with haemodialysis, patients with cardiac decompensation at the time of the intervention and those who did not tolerate the preparation by ischemic preconditioning in the non-dominant upper limb or who refused to participate in the study. The variables studied were age and gender, personal history of arterial hypertension, diabetes mellitus, chronic kidney disease and congestive heart failure, levels of estimated glomerular filtrate with the CKD-EPI formula, drugs that may affect renal function such as nephrotoxic medication (metformin, NSAIDs, aminoglycosides, glibenclamide or others) and drugs that can modify renal response to iodinated contrast (n-acetylcystein or sodium bicarbonate) and laboratory values: preoperative serum albumin creatinine, urea, hematocrit and urinary albumin/creatinine ratio in the preoperative period, at 24h and 48h of the administration of iodinated contrast and one month after the administration of iodinated contrast. Volume of iodinated contrast used, intraoperative serum therapy and during admission, type of endograft used, anesthetic technique, intraoperative drugs and in the immediate postoperative period and diuresis in the first 24h was also noted. The impact of preconditioning was measured in terms of absolute and relative creatinine variation in the first 48h according to the definition of contrast nephropathy detailed in section 1. 2.2. NEPHROPROTECTION PROTOCOL Within 12 hours prior to admission, fluid therapy was administered to all patients in order to prevent the onset of contrast nephropathy. The protocol was applied to all patients regardless of their risk (calculated with the Mehran risk scale) 21, with a regimen of 1ml/kg/hours for 12 hours before surgery. No other nephroprotective drugs such as N-acetylcystin or sodium bicarbonate were used unless the patient required them by prescription of another specialist. Nephrotoxic drugs were removed 24 hours before surgery (NSAIDs, metformin, aminoglycosides and glibenclamide). 2.3. PRECONDITIONING PROTOCOL In the 12 hours prior to surgery, the principal investigator performed the remote ischemic preconditioning (RIPC) following the protocol: 4 cycles of inflation/deflation of a pneumatic arterial tourniquet on the non-dominant upper extremity. Considering inflated a pressure of 50mmHg above systolic blood pressure for 5 minutes, followed by 5 minutes of deflation. Patients included in the preconditioning group were randomized at a rate of 1:1 consecutively. 2.4. ENDPOINTS The primary end point of this analysis was to determine 48h and 30-day postoperative CIN (using the above mentioned definition of an absolute increase of >0.5 mg/dl;44μmol/L or a relative increase of >25% of the serum creatinine between 48 - 72 hours after administration of iodinated contrast) in patients with aortic aneurysm who underwent endovascular repair. Hematocrit levels and urinary albumin:creatinine ratio at 48h and 30-day were also analyzed as secondary endpoints. 2.5. STATISTICAL ANALYSIS The sample size calculation based on the difference in mean serum creatinine during postoperative period being 0.7 mg/dl between control and RIPC group 19 in a population similar to that of our study. If these assumptions are correct, 37 patients per group would be sufficient to detect a difference of 0,5mg/dl in serum creatinine as defined by the Spanish Society of Nephrology 22. with a power of 80% and a two-sided type 1 error rate of 5% (GRANMO 5.2 statistical software). At the time 18 patients were recruited in each group, standard deviation of the population was 0.7, so a simple size recalculation was mandatory and resulted in 65 patients included in each group of treatment. We estimated 10% loss during follow-up. Normally distributed continuous variables are summarized with mean and standard deviation and compared using independent group t-tests for continuous variables and ANOVA for numeric variables with repeated values when the data were normally distributed; otherwise, the Mann-Whitney test was used. Continuous variables were tested for normality using the Shapiro-Wilk's test. Categorical variables were expressed as frequencies and percentages and compared by Pearson's chi-square or Fisher's exact test. For the binary outcomes concerning CIN within 30 days of endovascular aneurysm repair, univariate and multivariate logistic regressions were used. In the multivariate models, patient characteristics, comorbidities, and postoperative complications were used as covariables. Univariate and multivariate logistic regression analyses were performed, and odds ratios (ORs) with 95% confidence intervals (CIs) were reported. Two-sided P values<0.05 were considered statistically significant throughout. All the analyses were performed with the SPSS statistical software package (version 27.0; IBM Corporation, Somers, NY, USA).


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date May 20, 2020
Est. primary completion date September 17, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients scheduled for elective aortic surgery treated by endovascular repair Exclusion Criteria: - peripheral artery disease in the upper limbs - chronic kidney disease grade V on replacement therapy with haemodialysis, - - patients with cardiac decompensation at the time of the interventio - those who did not tolerate the preparation by ischemic preconditioning in the non-dominant upper limb or who refused to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Remote ischemic preconditioning
In the 12 hours prior to surgery, the principal investigator performed the remote ischemic preconditioning (RIPC) following the protocol: 4 cycles of inflation/deflation of a pneumatic arterial tourniquet on the non-dominant upper extremity. Considering inflated a pressure of 50mmHg above systolic blood pressure for 5 minutes, followed by 5 minutes of deflation. Patients included in the preconditioning group were randomized at a rate of 1:1 consecutively.

Locations

Country Name City State
Spain Hospital Clínico Universitario Valladolid

Sponsors (2)

Lead Sponsor Collaborator
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery Hospital Clínico Universitario de Valladolid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of contrast induces nephropathy in patients udergoing evar serum creatinine 48 hours
Primary Incidence of contrast induces nephropathy in patients udergoing evar serum creatinine 30 days
Primary Incidence of contrast induces nephropathy in patients udergoing evar Estimated glomerular filtrate 48 hours
Primary Incidence of contrast induces nephropathy in patients udergoing evar Estimated glomerular filtrate 30 days
Secondary Other variables urinary albumin:creatinine ratio 48 hours
Secondary Other variables Hematocrit levels 48 hours
Secondary Other variables urinary albumin:creatinine ratio 30 days
Secondary Other variables Hematocrit levels 30 days
See also
  Status Clinical Trial Phase
Recruiting NCT04149600 - Identification of Genetic Causes of Calcific Aortic Valve Disease
Enrolling by invitation NCT04035356 - HAART Annuloplasty Device Valve Repair Registry
Recruiting NCT02729064 - Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose Phase 1
Completed NCT02467062 - Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease. N/A
Completed NCT02283307 - Dual Energy CT Urography With Reduced Iodinated Contrast N/A
Completed NCT01678261 - X-chromosome Inactivation, Epigenetics and the Transcriptome N/A
Terminated NCT01055275 - Cook Iliac Branch Graft Post-market Registry N/A
Completed NCT00615888 - Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair N/A
Completed NCT03510793 - Microcirculation and Anesthesia in Vascular Surgery
Completed NCT03207568 - RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU) N/A
Recruiting NCT05073991 - Incidence of Mortality and Complications After Lung Surgery, Open Thoracic Aortic Repair, TEVAR, EVAR.
Not yet recruiting NCT01918969 - Reference Values of Circulating Endothelial Progenitor Cells N/A
Not yet recruiting NCT01918982 - Circulating Endothelial Progenitor Cells and Aortic Aneurysm N/A
Completed NCT02000544 - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit N/A
Completed NCT01256372 - An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery Phase 2
Recruiting NCT00661518 - PET/CT Imaging of Aneurysm Wall Inflammation N/A
Completed NCT00094575 - Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA) Phase 4
Recruiting NCT04471909 - NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness N/A
Recruiting NCT05603520 - Phenotyping Heterogeneity and Regionality of the Aorta
Completed NCT03727542 - Influence of Short AV Delay Permanent Pacing on Matrix Metalloproteinase Levels N/A