Clinical trial NCT03236831: AKI Prevention and Early Intervention in Patients Undergoing VAD Placement
Official title: AKI Prevention and Early Intervention in Patients Undergoing VAD Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Injury
Keywords: Ventricular Assist Device
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label single group interventional study
Primary purpose: PREVENTION

Brief summary: The investigators are doing this research to find out if more careful assessment and elimination of potential risk factors of acute kidney injury (AKI) during the subject's perioperative period will reduce their chance of kidney damage and kidney damage related problems.

Detailed description: The purpose of the study is to investigate whether preventive measures for patients undergoing ventricular assist device (VAD) placement will reduce AKI occurrence, progression and associated complications.

Participants will be in the study for a total of 6 days (1 day prior to the surgery and 5 days after the surgery). The investigators will review the participant's medical record up to one year after surgery.

The study investigators will access the participant's electronic medical record 24 hours prior to the planned VAD implantation and review the participant's medication regimen and provide recommendations to the participant's primary care physician in an effort to minimize potential risks for AKI. There will be no intervention during the operation.

The clinical recommendations will cover the following:

1. Avoidance of potentially nephrotoxic agents.
2. Optimizing volume status (avoidance of volume overload or depletion)
3. Optimizing electrolytes and acid-base status
4. Minimizing IV contrast exposure when appropriate
5. Treating severe anemia
6. Optimization of hemodynamics (Mean arterial BP\>65mmHg).

The investigators plan to compare the results of this study with the historical data in the same patient population in the years of 7/1/2015-6/30/2017.

Eligibility criteria: Inclusion criteria:

* Adult patients that will undergo VAD placement.
* Patients able to give consent

Exclusion criteria:

* Patients on dialysis (hemodialysis or peritoneal dialysis)
* Non-elective VAD placement (VAD implantation decision made within 24 hours)

Primary outcomes:
measure: Rate of postoperative AKI (within 5 post-op days) based on AKIN criteria
timeFrame: 5 days after the surgery
Secondary outcomes:
measure: Severity of postoperative AKI (within 5 post-op days) based on AKIN criteria
timeFrame: 5 days after the surgery
measure: Length of hospital stay
timeFrame: 1 year after the surgery
measure: In hospital (perioperative) mortality and one-year mortality
timeFrame: Approximately 5 days after surgery, one year after enrollment
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Qi Qian, M.D.
role: PRINCIPAL_INVESTIGATOR
References: