Dexmedetomidine and Renal Transplants | NCT02019121

Studies
Dexmedetomidine and Renal Transplants

NCT02019121

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

Jul 11, 2022Actual

Enrollment

797Actual

Phase

Not provided

Conditions

Renal Failure

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013Actual

Primary Completion Date

Feb 2020Actual

Completion Date

Feb 2020Actual

First Submitted Date

Nov 5, 2013

First Submission Date that Met QC Criteria

Dec 17, 2013

First Posted Date

Dec 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2022

Last Update Posted Date

Jul 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Investigators aim to retrospectively research patients undergoing renal transplants that received dexmedetomidine perioperatively to see if dexmedetomidine use protects renal function. Investigators hope to elucidate any association between renal transplant patients and perioperative dexmedetomidine administration, these include (but are not limited to) UOP, Cr/GFR, morbidity, mortality, in hospital complications and failure rate. Investigators will research both living and cadaveric renal transplants.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

797Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cr/GFR improvement, postoperative mortality/morbidity (within 30 days) and overall complications		5 years

Secondary Outcomes

Measure	Description	Time Frame
Graft failure, length of hospital stay (LOS), length of ICU stay, re-admission rate, infections, pulmonary complications.		5 years

Other Outcomes

Measure	Description	Time Frame
length of intubation time, and length of ventilation time		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Patients greater than or equal to 18 years old that underwent renal transplant at UC Davis Medical Center -

Exclusion Criteria: Patients that did not undergo renal transplants and patients less than 18 years old will be excluded from the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Renal transplant patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hong Liu, M.D.	University of California, Davis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Davis Health System		Sacramento	California	95817	United States

Label	URL
Learn more or sign up for the study here!	View source

Condition Browse Module

MeSH Terms

ID	Term
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided