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Measurement of Perioperative Glomerular Filtration Rate

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ClinicalTrials.gov Identifier: NCT03881332
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Lars Marius Ytrebo, University Hospital of North Norway

Brief Summary:
Our objective is to monitor glomerular filtration rate (GFR)during the perioperative phase of patients undergoing robotic surgery for rectum or large bowel cancers. We will use both a single injection and a continuous infusion of iohexol to measure kidney function for 72 hours after surgery.

Condition or disease
Rectal Cancer Colon Cancer

Detailed Description:

The considerable morbidity and mortality associated with perioperative acute kidney injury (AKI) is well documented and known to complicate recovery from surgery.

Accurate, direct measurements of glomerular filtration rate (GFR) may provide a tool to monitor perioperative onset of rapidly changing renal function. This may subsequently lead to design of randomized controlled trials examining the effects of earlier intervention with the aim to reduce the incidence of perioperative AKI.

Recently a protocol for continuous infusion of low-dose iohexol (CILDI) as a measure of GFR in stable patients over a range of GFR (28-128 mL/min/1.73 m2) has been developed. Accuracy of this infusion protocol was confirmed with the single bolus injection (SBI) method. Data also showed that the continuous infusion protocol of low-dose iohexol is an accurate and precise method when measuring changing GFR even in critical ill patients with variable AKI risks. Accordingly, SBI and CILDI together now allow us to explore unanswered research questions related to perioperative change in renal function.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Days
Official Title: Clinical Observational Study Using Iohexol to Measure Perioperative Glomerular Filtration Rate in Patients Undergoing Robotic Surgery for Rectum or Large Bowel Cancers
Estimated Study Start Date : April 26, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019



Primary Outcome Measures :
  1. Glomerular filtration rate [ Time Frame: 72 hours ]
    Measured glomerular filtration rate



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive elective rectum and colonic cancer patients due for robot surgery
Criteria

Inclusion Criteria:

  • Rectum or colon cancer

Exclusion Criteria:

  • Acute kidney injury grade 3 or higher

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881332


Contacts
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Contact: Lars Marius Ytrebo, PhD +47 90788058 lars.marius.ytrebo@unn.no
Contact: Stephen Hodges, PhD +47 40380666 shodges@rvc.ac.uk

Locations
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Norway
University Hospital of North Norway Recruiting
Tromsø, Troms, Norway, 9038
Contact: Lars M Ytrebø, MD PhD    +47 90788058    lars.marius.ytrebo@unn.no   
Sub-Investigator: Stephen Hodges, PhD         
Sponsors and Collaborators
University Hospital of North Norway
Investigators
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Study Chair: Lars Marius Ytrebo, PhD University Hospital of North Norway

Additional Information:

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Responsible Party: Lars Marius Ytrebo, Professor, University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT03881332     History of Changes
Other Study ID Numbers: 2018/1934
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No