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OpenTrials
Completed

NCT Number: NCT03236831

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.

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Key information

Conditions

Kidney Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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:

  • Avoidance of potentially nephrotoxic agents.
  • 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).

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Clinical Recommendations

Other

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)

Primary outcomes

  1. Rate of postoperative AKI (within 5 post-op days) based on AKIN criteria

    Time frame: 5 days after the surgery

    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

Secondary outcomes

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

    Time frame: 5 days after the surgery

    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

  2. Length of hospital stay

    Time frame: 1 year after the surgery

    The length of hospital stay will be determined from the electronic medical record.

  3. In hospital (perioperative) mortality and one-year mortality

    Time frame: Approximately 5 days after surgery, one year after enrollment

    The number of subjects who died in hospital (perioperatively) and one year after surgery

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 2, 2017
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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