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

NCT03368183 | Completed

• 1 other identifier: 99904021983
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality

  60 day (or in hospital mortality)

Study Arms (2)

SCAMP arm

EXPERIMENTAL

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

Other: Care delivery algorithim

Control arm "SHAM SCAMP

ACTIVE COMPARATOR

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

Care delivery algorithim OTHER

SCAMP

Control arm "SHAM SCAMP; SCAMP arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 34911731 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: In alternating months providers will be given the SCAMP vs. a shorter forms that does not include clinical decision support

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: December 11, 2017
• Study Start: July 1, 2017
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)