HOW DOES HEMODYNAMIC REGULATION AFFECTS GRAFT FUNCTIONS D... | NCT05753475

Studies
HOW DOES HEMODYNAMIC REGULATION AFFECTS GRAFT FUNCTIONS DURING RENAL TRANSPLANTATION?

NCT05753475

Sponsor

Ankara City Hospital Bilkent

Status

Unknown status

Last Update Posted

Mar 3, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Renal Transplant Failure and Rejection
Hypotension

Interventions

renal transplantation

Countries

Turkey (Türkiye)

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2023Estimated

Primary Completion Date

Apr 2023Estimated

Completion Date

Feb 2024Estimated

First Submitted Date

Feb 21, 2023

First Submission Date that Met QC Criteria

Mar 1, 2023

First Posted Date

Mar 3, 2023Actual

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

Mar 1, 2023

Last Update Posted Date

Mar 3, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ismail aytaç, Principal investigator, Ankara City Hospital BilkentPrincipal Investigator

Lead Sponsor

Ankara City Hospital BilkentOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The aim of the researchers was to evaluate the adequacy of graft function in the postoperative period of patients who underwent renal transplantation and encountered hypotension in the intraoperative period.

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

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hypotension			Other: renal transplantation
normotension			Other: renal transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
renal transplantation	Other	patients undergoing renal transplantation	hypotension normotension

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Systolic Blood Pressure		baseline
Mean Arterial Pressure		baseline
Systolic Blood Pressure		during the surgery
Mean Arterial Pressure		during the surgery
graft function		immediately after the surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing renal transplantation

Exclusion Criteria:

patient refusal

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

patients undergoing renal transplantation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara City Hospital		Ankara		06800	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012059	Rejection, Psychology
D007022	Hypotension

Ancestor Terms

ID	Term
D012919	Social Behavior
D001519	Behavior
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016030	Kidney Transplantation

Ancestor Terms

ID	Term
D017582	Renal Replacement Therapy
D013812	Therapeutics
D016377	Organ Transplantation
D014180	Transplantation

Browse Leaves

Not provided

Browse Branches

Not provided