"Volatile Anesthetic Protection Of Renal Transplants: VAPOR-1-trail

• Sponsor: University Medical Center Groningen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01248871
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Duration (Months): 25
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

To compare the renal protective properties of two currently used anaesthetic techniques - a sevoflurane-remifentanil/sufentanil combination with a propofol-remifentanil/sufentanil combination for anaesthesia in patients undergoing living donor kidney donation/transplantation.

Condition or Disease	Intervention/Treatment	Phase
Kidney Donation/Transplantation	Drug: procedure:sevoflurane-remifentanil/sufentanil; Drug: volatile agent only during reperfusion; Drug: propofol-remifentanil/sufentanil	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: "Volatile Anesthetic Protection Of Renal Transplants: VAPOR-1-trail
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SEVO sevoflurane-remifentanil/sufentanil combination	Drug: procedure:sevoflurane-remifentanil/sufentanil; Active Comparator
Active Comparator: SERE volatile agent only during reperfusion	Drug: volatile agent only during reperfusion; Active Comparator
Active Comparator: propofol propofol-remifentanil/sufentanil	Drug: propofol-remifentanil/sufentanil; Active Comparator

Outcome Measures

Primary Outcome Measures

1. To compare the renal protective properties of two currently used anaesthetic techniques [participants will be followed for the duration of hospital stay]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All patients: Age > 18 years

Exclusion Criteria:

• patient refusal

• BMI< 17, >35

• neurological disorder

• recent use of psycho-active medication, including alcohol.

• Donor-recipient couples from the ABO-incompatible program

• Altruistic donor

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Groningen	Groningen		Netherlands	9713 EZ

Sponsors and Collaborators

• University Medical Center Groningen

Investigators

• Principal Investigator: M.M.R.F Struys, Prof.dr., University Medical Center Groningen
• Principal Investigator: R,J. Ploeg, Prof.dr, University Medical Center Groningen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MMRF Struys, Prof.dr., University Medical Center Groningen
• ClinicalTrials.gov Identifier: NCT01248871
• Other Study ID Numbers: VAPOR 001
• First Posted: Nov 25, 2010
• Last Update Posted: Dec 19, 2012
• Last Verified: Dec 1, 2012

• Keywords provided by MMRF Struys, Prof.dr., University Medical Center Groningen: renal; transplantation; Volatile; anesthetic
• Additional relevant MeSH terms: Sufentanil; Remifentanil; Dsuvia; Propofol; Sevoflurane

Study Results

No Results Posted as of Dec 19, 2012