NCT02997748

Brief Summary

Acute kidney injury (AKI) is a well-recognized complication after cardiac surgery with cardiopulmonary bypass (CPB). The aim of this study is to reduce the incidence of AKI by implementing remote ischemic preconditioning and to evaluate the dose-response relationship using the biomarkers urinary \[TIMP-2\] \*\[IGFBP7\] in high risk patients undergoing 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
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

2.5 years

First QC Date

December 15, 2016

Last Update Submit

January 29, 2018

Conditions

Cardiac Surgery, Aortocoronary Bypass

Keywords

acute kidney injurycardiac surgeryRemote ischemic preconditioning[TIMP-2]*[IGFBP7]

Outcome Measures

Primary Outcomes (1)

  • Change in urinary [TIMP-2]*[IGFBP7]

    Biomarkers will be measured at different time points after to evaluate the effect of RIPC on \[TIMP-2\]\*\[IGFBP7\]

    within 12 hours after CPB

Secondary Outcomes (6)

  • AKI within 72 hours

    72 h

  • Dialysis within 7 days of surgery

    7 days

  • All-cause-mortality at 90 days

    90 d

  • Dialysis at day 90

    90 days

  • Renal recovery at day 90

    90 days

  • +1 more secondary outcomes

Study Arms (6)

Observational group

NO INTERVENTION

No intervention, standard care

Sham RIPC

SHAM COMPARATOR

Three cycles of 5- min upper limb sham ischemia

Procedure: Remote ischemic preconditioning (RIPC)

RIPC-Group 1

EXPERIMENTAL

Three cycles of 5- min upper limb ischemia

Procedure: Remote ischemic preconditioning (RIPC)

RIPC-Group 2

EXPERIMENTAL

Three cycles of 7-min upper limb ischemia

Procedure: Remote ischemic preconditioning (RIPC)

RIPC-Group 3

EXPERIMENTAL

Three cycles of 10-min upper limb ischemia

Procedure: Remote ischemic preconditioning (RIPC)

RIPC-Group 4

EXPERIMENTAL

Three Cycles of 5-min upper limb ischemia. If there is no response this will be followed by 2 cycles of 10-min upper-limb ischemia

Procedure: Remote ischemic preconditioning (RIPC)

Interventions

Remote ischemic preconditioning (RIPC)PROCEDURE

3 cycles or more cycles of 5 to 10-min inflation of a blood-pressure cuff to 200 mm HG (or at least to a pressure 50 mmHG higher than the systolic arterial pressure) to one upper arm followed by 5 min reperfusion with the cuff deflated. In Non-Responder two additional cycles of 10 min cuff inflation will be performed in arm 6.

RIPC-Group 1RIPC-Group 2RIPC-Group 3RIPC-Group 4Sham RIPC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are scheduled to undergo cardiac surgery with cardiopulmonary bypass
  • Cleveland Clinic Score \>=6

You may not qualify if:

  • Acute myocardial infarction up to 7 days before surgery
  • Age \< 18 years
  • Off-pump cardiac surgery
  • Preexisting AKI
  • Chronic kidney disease (GFR \< 30 ml/min)
  • Kidney transplantation within the last 12 months
  • Peripheral arterial occlusive disease
  • Pregnancy
  • Hepatorenal syndrome
  • Sulfonamide or thiazide medication within the last 7 days
  • Participation in another interventional trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Muenster

Münster, D-48149, Germany

RECRUITING

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

  • Melanie Meersch

    University Hospital Muenster

    STUDY CHAIR

Central Study Contacts

Melanie Meersch, MD

CONTACT

+49-251-8347282aki@anit.uni-muenster.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 20, 2016

Study Start

December 1, 2016

Primary Completion

June 1, 2019

Study Completion

September 1, 2019

Last Updated

January 30, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)