NCT03632538

Brief Summary

Acute kidney injury (AKI) is a common and major complication of cardiac surgery. The aim of this study is to evaluate the use of a fragment of proencephalin in plasma and other biomarkers as specific markers for early diagnosis of AKI and the need of renal replacement therapy after cardiac surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

July 27, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

2.9 years

First QC Date

July 27, 2018

Last Update Submit

April 4, 2020

Conditions

Acute Kidney InjuryRenal Replacement Therapy

Keywords

Acute Kidney InjuryCardiac Surgery

Outcome Measures

Primary Outcomes (2)

  • AKI 0 h

    Diagnosis and severity of acute kidney injury following the KDIGO-criteria

    after operation (surgery): 0 hours

  • AKI 6 h

    Diagnosis and severity of acute kidney injury following the KDIGO-criteria

    after operation (surgery): 6 hours

Secondary Outcomes (1)

  • SOFA

    before operation, after operation (times: 0, 6, 24, 72 and 168 hours

Study Arms (2)

Male

20 male adult patients after cardiac surgery. Drawing of patients blood for measurement of biomarkers ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide) for AKI before and after cardiac surgery (times: 0, 6, 24, 72, 168 hours).

Diagnostic Test: Biomarker ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide)

Female

20 female adult patients after cardiac surgery. Drawing of patients blood for measurement of biomarkers ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide) for AKI before and after cardiac surgery (times: 0, 6, 24, 72, 168 hours).

Diagnostic Test: Biomarker ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide)

Interventions

Biomarker ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide)DIAGNOSTIC_TEST

Drawing of patients blood for measurement of biomarkers for AKI before and after cardiac surgery (times: 0, 6, 24, 72, 168 hours).

FemaleMale

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details20 female and 20 male patients.
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients undergoing cardiac surgery and fulfilling the inclusion criteria should be screened for the study at the university hospital of Rostock, Germany at one of the two different intensive care units PIT 1 and 2 at the Department of Anaesthesiology and Intensive Care or at the Department of Cardiac Surgery.

You may qualify if:

  • Female or male, at least 18 years old
  • Ability to consent to the study by patient or legal representative
  • Cardiac surgery with use of extracorporeal circulation (ECC)
  • Bypass (\> 2; ACB) or bypass + heart valve surgery
  • Two or three heart-valve operation

You may not qualify if:

  • Dialysis-dependent patients with chronic, end-stage renal failure
  • Pre-existing renal replacement therapy
  • Infused prognosis (expected death in ≤ 12 hours despite maximal therapy)
  • Inability to consent of participation in the research project, of the patient or of the patients representative
  • Aortic surgery
  • Endocarditis
  • (Only) partial sternotomy (eg. aortic valve surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Units PIT 1+2, University hospital Rostock

Rostock, 18055, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Each 8 ml blood drawn from patients for measurement of biomarkes to 6 time points.

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

  • Martin Sauer, MD

    University Hospital of Rostock, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Sauer, MD

CONTACT

+493814946409martin.sauer@uni-rostock.de

Sandra Doß

CONTACT

+493814942640sandra.doss@med.uni-rostock.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PD Dr. med. habil.

Study Record Dates

First Submitted

July 27, 2018

First Posted

August 15, 2018

Study Start

July 27, 2018

Primary Completion

July 1, 2021

Study Completion

October 1, 2021

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations

DE(1)