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OpenTrials
Completed

NCT Number: NCT03236103

AKI Prevention and Early Intervention in VAD Patients Admitted for Acute Medical Events.

The investigators are doing this research to investigate whether multifaceted preventive measures for newly hospitalized ventricular assist device (VAD) patients will reduce the Acute Kidney Injury (AKI) occurrence rate, progression and associated complications

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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About this study

The purpose of the study is to investigate whether preventive measures for newly hospitalized ventricular assist device (VAD) patients will reduce the Acute Kidney Injury (AKI) occurrence rate, progression and associated complications

Participants will be in the study for the first 7 days of hospitalization. The study investigators will access the electronic medical record daily from admission day 1 through admission day 7 in order to provide clinical recommendations in an effort to minimize AKI risk as per routine practice.

If the patient is discharged prior to day 7 the study, intervention will be terminated on day of discharge.

The investigators will review the participant's medical record up to one year after surgery.

This study will not include any experimental laboratory tests or experimental medication.

The clinical recommendations will regard the following:

  • Avoidance of potentially nephrotoxic medications (e.g. NSAIDs, intravascular contrast, nephrotoxic antimicrobials)
  • Optimizing volume status (avoidance of volume overload or depletion)
  • Optimizing electrolytes and acid-base status
  • Optimizing hemodynamics (Mean arterial BP>65mmHg)
  • Assessment of kidney function with serum creatinine and/or cystatin C None of the suggestions will be experimental. All suggestions will be based on standard nephrology practice.

The investigators plan to compare the results of the current study with those in in the years of 2012-2017 (1/7/2012- 1/7/2017) via retrospective chart review

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adult patients with VAD in place who are admitted to the hospital for acute medical illness during the study period. For those with multiple admissions during the study period only the first admission will be studied.

Patients who are able to give consent. In case of patients that are mentally impaired we will obtain consent from power of attorney and when patients regain intact mental capacity we will reobtain consent from the patient.

Exclusion criteria

Patients on dialysis (hemodialysis or peritoneal dialysis).

Treatment and study plan

Clinical Recommendations

Other

The clinical recommendations will regard the following:

  • Avoidance of potentially nephrotoxic medications (e.g. NSAIDs, intravascular contrast, nephrotoxic antimicrobials)
  • Optimizing volume status (avoidance of volume overload or depletion)
  • Optimizing electrolytes and acid-base status
  • Optimizing hemodynamics (Mean arterial BP>65mmHg)
  • Assessment of kidney function with serum creatinine and/or cystatin C

None of the suggestions will be experimental. All suggestions will be based on standard nephrology practice.

Primary outcomes

  1. Rate of AKI in hospitalized VAD patients based on AKIN criteria

    Time frame: The first 7 days of hospitalization

    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. Severity of AKI based on AKIN stages (I, II, III) 1

    Time frame: The first 7 days of the hospitalization

    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

Secondary outcomes

  1. Length of hospital stay

    Time frame: One year after hospitalization

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

  2. In hospital, 60 day and one-year mortality

    Time frame: One year after enrollment

    The number of subjects who died during hospitalization, 60 days after hospitalization and one year after hospitalization

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 1, 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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