Measurement of Perioperative Glomerular Filtration Rate

Completed

• Conditions: Rectal Cancer; Colon Cancer

• Registration Number: NCT03881332
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2019-03-16
• Study First Submitted QC: 2019-03-17
• Study First Posted: 2019-03-19
• Study Start: 2019-12-26
• Status Verified: 2021-01
• Primary Completion: 2021-01-22
• Study Completion: 2021-01-22
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Rectum or colon cancer

Exclusion Criteria

• Acute kidney injury grade 3 or higher

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glomerular filtration rate	72 hours	Measured glomerular filtration rate

Trial Locations

Locations (1)

University Hospital of North Norway; 🇳🇴 Tromsø, Troms, Norway