AKI Prevention and Early Intervention in Patients Undergoing VAD Placement

NCT03236831 | Completed

• 1 other identifier: 17-001893
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Injury

Keywords

Ventricular Assist Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Severity of postoperative AKI (within 5 post-op days) based on AKIN criteria

  5 days after the surgery

• Length of hospital stay

  1 year after the surgery

• In hospital (perioperative) mortality and one-year mortality

  Approximately 5 days after surgery, one year after enrollment

Study Arms (1)

Subjects Undergoing Prospective VAD

OTHER

Patients undergoing VAD placement. The investigators will provide clinical recommendations to the subject's primary care provider.

Other: Clinical Recommendations

Interventions

Clinical Recommendations OTHER

The investigators will provide clinical recommendations to the subject's primary care provider. These will be in regards to the following: 1. Avoidance of potentially nephrotoxic medications. 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)

Subjects Undergoing Prospective VAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Qi Qian, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Physiology

Model Details: Open label single group interventional study

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 2, 2017
• Study Start: April 11, 2017
• Primary Completion: February 17, 2019
• Study Completion: February 17, 2019
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

US (1)