NCT03335865

Brief Summary

The purpose of this study is to assess the feasibility of measuring urine oxygen tension in cardiac surgery patient and the ability of peri-operative urine oxygen measurements to predict post-operative acute kidney injury. The hypothesis is that a small oxymeter placed in a urinary catheter will provide reliable measurement of urine oxygenation and that these measurements will predict post-operative acute kidney injury in cardiac surgery patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

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

First Submitted

Initial submission to the registry

October 25, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2019

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

1.5 years

First QC Date

October 25, 2017

Last Update Submit

April 24, 2023

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Acute Kidney Injury, change in creatinine

    Defined as a rise in creatinine of at least .3 mg/dl or more in 48 hours or a rise of at least 1.5 times baseline

    Creatinine is assessed as standard of care pre-operatively while in hospital (baseline) and every morning starting from the first day post-operative to discharge, an average of 5 days post-operative

Secondary Outcomes (11)

  • urine flow rate

    recorded continuously through out the entire operative period, before, during, and after CPB, into the intensive care unit, and up to 48 hrs post-operatively or until the urinary catheter is removed

  • Acute kidney injury biomarkers TIMP-2 and IGFBP7

    pre-operatively, every 30 minutes intra-operatively, 4, 12, and 24 hours post-operative

  • Vital signs

    highest, lowest, and mean intra-operative blood pressure and highest, lowest, and mean blood pressure while in the ICU for up to 48 hours

  • Vital signs

    highest, lowest, and mean intra-operative heart rate and highest, lowest, and mean heart rate while in the ICU for up to 48 hours

  • Vital signs

    highest, lowest, and mean intra-operative pulmonary artery pressure and highest, lowest, and mean pulmonary artery pressure pressure while in the ICU for up to 48 hours

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elective or semi-elective/urgent Cardiac surgery patients aged 18 and older in whom CPB is a planned part of the procedure and a urinary catheter is planned during the surgery will be enrolled. Patients with contra-indications to urinary catheter or pre-operative dialysis dependent end stage renal disease, and emergency cases will be excluded.

You may qualify if:

  • Elective or semi-elective/urgent Cardiac surgery patients in whom CPB is a planned part of the procedure.
  • years or older
  • Urinary catheter is planned during the surgery

You may not qualify if:

  • Contra-indications to urinary catheter
  • Pre-operative dialysis dependent end stage renal disease
  • Emergency cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

  • Lofgren LR, Silverton NA, Kuck K, Hall IE. The impact of urine flow on urine oxygen partial pressure monitoring during cardiac surgery. J Clin Monit Comput. 2023 Feb;37(1):21-27. doi: 10.1007/s10877-022-00843-z. Epub 2022 Jun 1.

    PMID: 35648329DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

1-2 ml of urine will be collected every 30 minutes while in the operating room, then at 4 hours and 24 hours after CBP. These samples will be labeled by study number and then stored for later biomarker analysis.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Natalie Silverton, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 25, 2017

First Posted

November 8, 2017

Study Start

March 1, 2018

Primary Completion

September 12, 2019

Study Completion

September 12, 2019

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations

US(1)