NCT00595179

Brief Summary

Current assessment of organ tissue viability by surgeons in the operating room is limited to crude estimates such as overt physical examination, measurement of laboratory values and physical measurements of vascular flow and resistance. The ability to non-invasively measure tissue perfusion and oxygenation would provide the surgeon an improved means to assess if an injured organ will survive. The recent development of real time infrared (IR) and Near Infrared Imaging Spectroscopy (NIRIS) digital cameras has allowed for the determination of tissue perfusion and oxygenation in a non-invasive fashion. Although in the early stages of development, the application of infrared and NIRS technology holds great promise to permit the surgeon to better assess the viability of tissues in ways that have not been possible. We propose to evaluate infrared and NIRS technology in the assessment of kidney allografts using data previously collected during recipient operations at the NIH.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

First QC Date

January 3, 2008

Last Update Submit

April 4, 2012

Conditions

Keywords

InfraredImaging TechniquesKidney ReperfusionPneumoperitoneumNephrectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • NIH Transplant Reccipients of living related, living unrelated, and cadaveric kidney transplants who underwent intra-operative IR/NIRS imaging.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK), 9000

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Gorbach AM, Heiss J, Kufta C, Sato S, Fedio P, Kammerer WA, Solomon J, Oldfield EH. Intraoperative infrared functional imaging of human brain. Ann Neurol. 2003 Sep;54(3):297-309. doi: 10.1002/ana.10646.

    PMID: 12953262BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 16, 2008

Study Start

December 1, 2007

Study Completion

January 1, 2012

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations