Kidney InjuryNCT03236831
AKI Prevention and Early Intervention in Patients Undergoing VAD Placement
A study testing Clinical Recommendations in people with Kidney Injury, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Injury
- What is being tested?
- Clinical Recommendations
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2017to 17 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients that will undergo VAD placement.
- Patients able to give consent
Who cannot join
- Patients on dialysis (hemodialysis or peritoneal dialysis)
- Non-elective VAD placement (VAD implantation decision made within 24 hours)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the 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:
- 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.
- Conditions
- Kidney Injury
- Being tested
- Clinical Recommendations
- Keywords
- Ventricular Assist Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical RecommendationsOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Subjects Undergoing Prospective VAD | Other | Patients undergoing VAD placement. The investigators will provide clinical recommendations to the subject's primary care provider. Receives: Other: Clinical Recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 days after the surgery
Secondary outcomes (3)
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
Measured: 5 days after the surgery
Length of hospital stay
The length of hospital stay will be determined from the electronic medical record.
Measured: 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
Measured: Approximately 5 days after surgery, one year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start11 Apr 2017
- Primary completion17 Feb 2019
- Study completion17 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label single group interventional study
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qi Qian, M.D., Mayo Clinic
- Investigators
- Qi Qian, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236831
- Sponsor's protocol ID
- 17-001893
- Status last verified
- Oct 2019
- First submitted
- 28 Jul 2017
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AKI Prevention and Early Intervention in Patients Undergoing VAD Placement
- ClinicalTrials.gov ID
- NCT03236831
- Acronym / sponsor ID
- 17-001893
- Conditions
- Kidney Injury
- Keywords
- Ventricular Assist Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 17 Feb 2019 (actual)
- Study completion
- 17 Feb 2019 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label single group interventional study
| Arm | Type | Receives |
|---|---|---|
| Subjects Undergoing Prospective VAD | Other | Other: Clinical RecommendationsPatients undergoing VAD placement. The investigators will provide clinical recommendations to the subject's primary care provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients that will undergo VAD placement.
- Patients able to give consent
Key exclusion criteria (2 listed)
- Patients on dialysis (hemodialysis or peritoneal dialysis)
- Non-elective VAD placement (VAD implantation decision made within 24 hours)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical RecommendationsThe 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) | Other | Subjects Undergoing Prospective VAD |
Primary outcome
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
3 secondary outcomes
Severity of postoperative AKI (within 5 post-op days) based on AKIN criteria
Time frame: 5 days after the surgery
Length of hospital stay
Time frame: 1 year after the surgery
In hospital (perioperative) mortality and one-year mortality
Time frame: Approximately 5 days after surgery, one year after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Injury
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
RecruitingPhase 4
Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment
Ureter Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qi Qian, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Recommendations in people with Kidney Injury, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperative AKI (within 5 post-op days) based on AKIN criteria (time frame: 5 days after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.