NCT02405195

Brief Summary

Acute kidney injury is a common complication after cardiac surgery with cardiopulmonary bypass (CPB). This study aims to investigate the effects of CPB on renal perfusion, filtration and oxygenation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 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

October 1, 2011

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

May 7, 2019

Completed
Last Updated

May 7, 2019

Status Verified

February 1, 2019

Enrollment Period

4.2 years

First QC Date

March 27, 2015

Results QC Date

April 27, 2018

Last Update Submit

February 4, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Renal Blood Flow (RBF)

    Renal blood flow measured with PAH clearance

    6 hours

  • Glomerular Filtration Rate (GFR)

    GFR measured by renal extraction of 51Cr-EDTA

    6 hours

  • Renal Oxygenation

    Renal oxygen extraction, defined as renal oxygen consumption divided by renal oxygen delivery

    6 hours

Secondary Outcomes (2)

  • Excretion of NAG

    24 hours

  • Development of Acute Kidney Injury (AKI)

    72 hours

Interventions

During cardiac surgery, the subjects are routinely undergoing cardiopulmonary bypass

Also known as: extracorporeal circulation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Elective complex cardiac surgery

You may qualify if:

  • Preserved left ventricular function (LVEF \> 50%)
  • Normal preoperative S-creatinine

You may not qualify if:

  • Contraindications to radiocontrast
  • Cardiac transplantation och dissection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of thoracic anesthesia, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (1)

  • Lannemyr L, Bragadottir G, Redfors B, Ricksten SE. Effects of milrinone on renal perfusion, filtration and oxygenation in patients with acute heart failure and low cardiac output early after cardiac surgery. J Crit Care. 2020 Jun;57:225-230. doi: 10.1016/j.jcrc.2019.12.022. Epub 2020 Jan 6.

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Cardiopulmonary BypassExtracorporeal Circulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Results Point of Contact

Title
Lukas Lannemyr
Organization
Västra Götalandsregionen

Study Officials

  • Sven-Erik Ricksten, Professor

    Sahlgrenska Academy, dept of clinical science

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

March 27, 2015

First Posted

April 1, 2015

Study Start

October 1, 2011

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

May 7, 2019

Results First Posted

May 7, 2019

Record last verified: 2019-02

Locations