AKI Prevention and Early Intervention in Patients Undergoing VAD Placement

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.

Study Overview

• Status: Completed
• Conditions: Kidney Injury
• Intervention / Treatment: Other: Clinical Recommendations

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.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Subjects Undergoing Prospective VAD; Patients undergoing VAD placement. The investigators will provide clinical recommendations to the subject's primary care provider.

Other: Clinical Recommendations; The investigators will provide clinical recommendations to the subject's primary care provider. These will be in regards to the following: Avoidance of potentially nephrotoxic medications.; Optimizing volume status (avoidance of volume overload or depletion); Optimizing electrolytes and acid-base status; Minimizing IV contrast exposure when appropriate; Treating severe anemia; Optimization of hemodynamics (Mean arterial BP>65mmHg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of postoperative AKI (within 5 post-op days) based on AKIN criteria	The Acute Kidney Injury Network (AKIN) staging system has 3 stages: 1) serum creatinine increase ≥ 26.5 umol/L or increase to 1.5-2.0 fold from baseline, OR urine output <0.5 ml/kg/h for 6 h; 2) serum creatinine increase > 2.0-3.0 fold from baseline OR urine output <0.5 ml/kg/h for 12 h; 3) serum creatinine increase >3.0 fold from baseline OR serum creatinine ≥354 umol/l with an acute increase of at least 44 umol/l or need for Renal Replacement Therapy (RRT) OR urine output <0.3 ml/kg/h for 24 h OR anuria for 12 OR need for RRT	5 days after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of postoperative AKI (within 5 post-op days) based on AKIN criteria	The AKIN staging system has 3 stages: 1) serum creatinine increase ≥ 26.5 umol/L or increase to 1.5-2.0 fold from baseline, OR urine output <0.5 ml/kg/h for 6 h; 2) serum creatinine increase > 2.0-3.0 fold from baseline OR urine output <0.5 ml/kg/h for 12 h; 3) serum creatinine increase >3.0 fold from baseline OR serum creatinine ≥354 umol/l with an acute increase of at least 44 umol/l or need for Renal Replacement Therapy (RRT) OR urine output <0.3 ml/kg/h for 24 h OR anuria for 12 OR need for RRT	5 days after the surgery
Length of hospital stay	The length of hospital stay will be determined from the electronic medical record.	1 year after the surgery
In hospital (perioperative) mortality and one-year mortality	The number of subjects who died in hospital (perioperatively) and one year after surgery	Approximately 5 days after surgery, one year after enrollment

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Qi Qian, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Actual): February 17, 2019
• Study Completion (Actual): February 17, 2019

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (Actual): August 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Ventricular Assist Device
• Other Study ID Numbers: 17-001893

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No