NCT02410642

Brief Summary

NAG is a protein excreted in urine in cases of tubular damage, and is considered a biomarker of kidney injury. Elevated urinary NAG is seen after cardiac surgery, but the clinical significance, pattern of excretion and links to perioperative factors are poorly described. We plan a study of the pattern of NAG-excretion during cardiac surgery with cardiopulmonary bypass, and explore possible associated variables.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2011

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

November 1, 2011

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

4.1 years

First QC Date

April 2, 2015

Last Update Submit

March 7, 2016

Conditions

Renal Impairment

Keywords

cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

  • Urinary NAG secretion

    Secretion pattern of NAG

    24 hours

Secondary Outcomes (1)

  • Development of AKI (acute kidney injury) according to AKIN criteria

    72 hours

Other Outcomes (1)

  • Perioperative factors influencing NAG-secretion

    24 hours

Interventions

cardiopulmonary bypassPROCEDURE

Routine use of cardiopulmonary bypass as needed during cardiac surgery

Eligibility Criteria

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

60 patients scheduled for complex cardiac surgery

You may qualify if:

  • Expected cardiopulmonary bypass time exceeding 60 minutes
  • Elective surgery

You may not qualify if:

  • End-stage kidney disease with dialysis
  • Ongoing treatment with nephrotoxic antibiotic agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of thoracic anesthesia, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Cardiopulmonary Bypass

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Extracorporeal CirculationSurgical Procedures, Operative

Study Design

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

Study Record Dates

First Submitted

April 2, 2015

First Posted

April 7, 2015

Study Start

November 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

SE(1)