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CompletedNCT03368183Updated Aug 10, 2022

Acute Kidney Injury Standardized Clinical Assessment and Management Plan for Renal Replacement Initiation

An interventional study of Care delivery algorithim in Acute Kidney Injury, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-10.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
224
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is of a clinical decision support tool for clinicians taking care of patients with severe acute kidney injury in the intensive care unit. Nephrologists will be given a standardized clinical assessment and management plan (SCAMP), which is a tool to assist clinicians in decision making on the need for renal replacement therapy (Mendu et al., CJASN 2017). In alternating months, nephrologists will be given the SCAMP vs. another simplified form. The goal is to test whether patients whose clinicians are asked to fill out the SCAMP have improved outcomes compared to the control group. The investigators are also collecting information about provider adherence to the SCAMP and deviations from the SCAMP recommendations to understand clinical decision making related to renal replacement.

Read the detailed description

Background: Acute Kidney Injury (AKI) is common among critically ill patients and is associated with substantial morbidity and mortality. Severe AKI requiring renal replacement therapy (RRT) is associated with in-hospital mortality rates exceeding 40%. The investigators designed and implemented an AKI Standardized Clinical Assessment and Management Plan (SCAMP), a decision-making algorithm to assist front-line nephrologists caring for patients with AKI. The investigators piloted the implementation of the AKI SCAMP in the medical intensive care unit at Brigham and Women's Hospital prospectively over the course of 1-year, and illustrated that patients whose nephrologists adhered to the SCAMP recommendations had lower in-hospital mortality. The investigators have a publication in press in the Clinical Journal of the American Society of Nephrology detailing our findings (Mendu et al. CJASN January 2017).

Aims: The primary aim of this study is to expand the prospective implementation of the AKI SCAMP to multiple intensive care units (ICUs) at Brigham and Women's Hospital in an interrupted time series study (nephrologists will be asked to complete the AKI SCAMP alternate months). The investigators aim to test the hypothesis generated by our pilot study, that the utilization of an AKI SCAMP by providers in a critical care setting can reduce in-hospital mortality. Expanding to multiple ICUs and introducing a time series design will mitigate the limitations of our pilot data, such as a small sample size and confounding by disease severity.

Design: The investigators seek to conduct a prospective interrupted time series study of the implementation of an AKI SCAMP utilized by nephrologists in intensive care units during the time period of 1 year to determine if utilization of the AKI SCAMP reduces in-hospital mortality.

02

Conditions studied

  • Acute Kidney Injury
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Acute kidney injury, followed by nephrology consult service
  • Intensive care unit

Exclusion criteria

Exclusion Criteria:

  • End stage renal disease
  • Renal replacement therapy for advanced chronic kidney disease rather than acute kidney injury.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
224 participants (actual)

Study arms

  • Experimental
    SCAMP arm

    The SCAMP is a clinical decision support tool. See Mendu et al. CJASN 2017.

    Other: Care delivery algorithim

  • Active comparator
    Control arm "SHAM SCAMP

    The control arm will be a form that asks questions about indications for renal replacement therapy but does not provide suggestions about when to initiate renal replacement therapy, as is being done in the active SCAMP arm. The goal of the control group is to test whether the SCAMP clinical decision support influences provider practice patterns and improves care.

    Other: Care delivery algorithim

Interventions

  • OtherCare delivery algorithim

    SCAMP

05

What researchers measure

Primary outcomes

  1. Mortality

    Mortality

    Time frame: 60 day (or in hospital mortality)

06

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02215, United States
07

References and documents

Publications

  • Kelly YP, Mistry K, Ahmed S, Shaykevich S, Desai S, Lipsitz SR, Leaf DE, Mandel EI, Robinson E, McMahon G, Czarnecki PG, Charytan DM, Waikar SS, Mendu ML. Controlled Study of Decision-Making Algorithms for Kidney Replacement Therapy Initiation in Acute Kidney Injury. Clin J Am Soc Nephrol. 2022 Feb;17(2):194-204. doi: 10.2215/CJN.02060221. Epub 2021 Dec 15. PubMed 34911731 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03368183
Lead sponsor
Brigham and Women's Hospital
Responsible party
Sushrut S Waikar (Associate Professor of Medicine, Brigham and Women's Hospital) — Principal investigator
First posted
Dec 11, 2017
Start date
Jul 1, 2017
Primary completion
Feb 28, 2022
Completion
Feb 28, 2022
Last update
Aug 10, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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