Comparison between Ringer and Custodiol in renal perfusion during thoracoabdominal aortic surgery

CUstodiol vs RInger: whaT Is the Best Agent? - CURITIBA TRIAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003818-92-IT

Enrollment

Registered

2014-10-31

Start date

2014-12-22

Completion date

Unknown

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracoabdominal aortic aneurysm MedDRA version: 17.1 Level: PT Classification code 10002882 Term: Aortic aneurysm System Organ Class: 10047065 - Vascular disorders

Interventions

Trade Name: Custodiol Product Name: Custodiol Pharmaceutical Form: Solution for organ preservation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Age = 18 years 2 Ability to provide written informed consent 3 Patient underwent surgery for thoraco-abdominal aortic aneurysmectomy with need for renal perfusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: 1 Patients who have participated in a drug trial in the previous three months 2 Intervention under emergency / urgency 3 Patient uncooperative and / or mental changes 4 Referred allergy or intolerance to the study drug 5. Any contraindication shown on the Summary of Product Characteristics (SPC) of the study drugs Patient 6 in renal replacement treatment (dialysis) at the time of 7 Women who are pregnant or breast-feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: ASSESSING THE EFFECTIVENESS OF RENAL PERFUSION WITH CUSTODIOL IN REDUCING THE RENAL DAMAGE AFTER SURGICAL;Secondary Objective: ASSESSING VALIDITY 'BIOMARKER OF SERUM AND URINE FROM KIDNEY DAMAGE SUB-CLINICAL AND CLINICAL POST-ISCHEMIC;Primary end point(s): Make a significant reduction of acute renal failure (AKI - Defined according to the diagram 2013.9 KDIGO see Table 1) in postoperative surgical patients who receive renal perfusion with respect to Custodiol those who receive standard perfusion with Ringer's lactate solution ;Timepoint(s) of evaluation of this end point: 28 DAYS	—

Measure

Time frame

Main Objective: ASSESSING THE EFFECTIVENESS OF RENAL PERFUSION WITH CUSTODIOL IN REDUCING THE RENAL DAMAGE AFTER SURGICAL;Secondary Objective: ASSESSING VALIDITY 'BIOMARKER OF SERUM AND URINE FROM KIDNEY DAMAGE SUB-CLINICAL AND CLINICAL POST-ISCHEMIC;Primary end point(s): Make a significant reduction of acute renal failure (AKI - Defined according to the diagram 2013.9 KDIGO see Table 1) in postoperative surgical patients who receive renal perfusion with respect to Custodiol those who receive standard perfusion with Ringer's lactate solution ;Timepoint(s) of evaluation of this end point: 28 DAYS

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Secondary

Measure	Time frame
Secondary end point(s): • perioperative trend (from the preoperative to the sixth postoperative day) of the estimated glomerular filtration rate (eGFR) calculated on a daily basis using the formula Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 10 between the two groups of renal perfusion • identify independent predictors of postoperative acute renal failure • length of stay in the Intensive Care Unit (ICU) • in-hospital length of stay • In-hospital mortality, 28-day and one year after surgery. ;Timepoint(s) of evaluation of this end point: • perioperative trend (from the preoperative to the sixth postoperative day) of the estimated glomerular filtration rate (eGFR) calculated on a daily basis using the formula Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 10 between the two groups of renal perfusion • identify independent predictors of postoperative acute renal failure (28 days) • length of stay in the Intensive Care Unit (ICU) (60 days) • in-hospital length of stay (60 days) • In-hospital mortality, 28-day and one year after surgery.	—

Measure

Time frame

Secondary end point(s): • perioperative trend (from the preoperative to the sixth postoperative day) of the estimated glomerular filtration rate (eGFR) calculated on a daily basis using the formula Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 10 between the two groups of renal perfusion • identify independent predictors of postoperative acute renal failure • length of stay in the Intensive Care Unit (ICU) • in-hospital length of stay • In-hospital mortality, 28-day and one year after surgery. ;Timepoint(s) of evaluation of this end point: • perioperative trend (from the preoperative to the sixth postoperative day) of the estimated glomerular filtration rate (eGFR) calculated on a daily basis using the formula Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 10 between the two groups of renal perfusion • identify independent predictors of postoperative acute renal failure (28 days) • length of stay in the Intensive Care Unit (ICU) (60 days) • in-hospital length of stay (60 days) • In-hospital mortality, 28-day and one year after surgery.

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Countries

Italy

Contacts

Public ContactUO Chirurgia Vascolare

Ospedale San Raffaele

00390226437377

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026