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Procedure

Pulsatile Blood Flow for Reducing Acute Kidney Injury

N/A
Waitlist Available
Led By Nathan J Clendenen, MD, MS
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from intensive care unit admission after surgery to hospital discharge, up to 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if using a specific type of blood flow during heart surgery can help reduce the risk of kidney damage. Researchers will also look at how safe and effective this method is compared to the

Who is the study for?
This trial is for patients undergoing cardiac surgery who will be on cardiopulmonary bypass. It's not clear what specific conditions or characteristics make someone eligible or ineligible to participate.
What is being tested?
The study is testing if pulsatile blood flow (mimicking natural heartbeat rhythms) during cardiopulmonary bypass can reduce kidney damage after heart surgery, compared to non-pulsatile flow (steady stream).
What are the potential side effects?
Potential side effects are not specified, but may include complications related to changes in blood flow during surgery such as increased risk of bleeding, clotting issues, or other impacts on organ function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from intensive care unit admission after surgery to hospital discharge, up to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and from intensive care unit admission after surgery to hospital discharge, up to 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acute kidney injury
Secondary study objectives
30-day mortality
Acute kidney injury risk score
Discontinuation rate of cardiopulmonary bypass mode
+2 more
Other study objectives
Duration of mechanical ventilation
Intra-operative cryoprecipitate transfusion in units
Intra-operative plasma transfusion in units
+18 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Pulsatile blood flowActive Control1 Intervention
Pulsatile blood flow during cardiopulmonary bypass
Group II: Non-pulsatile blood flowActive Control1 Intervention
Non-pulsatile blood flow during cardiopulmonary bypass

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,821,800 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,791,221 Total Patients Enrolled
Nathan J Clendenen, MD, MSPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
66 Total Patients Enrolled
~733 spots leftby Apr 2028
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