Study Stopped
Covid pandemic
Surveillance of High-risk Early Postsurgical Patients for Real-time Detection of Complications
SHEPHERD
1 other identifier
interventional
747
1 country
2
Brief Summary
The aim of this study is to test the hypothesis that continuous wireless monitoring on the postsurgical ward will improve patient outcome, measured as disability-free survival at three months after surgery. Further, the investigators hypothesize that this tight control regimen decreases length of hospital stay and treatment costs in patients with complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2016
CompletedFirst Posted
Study publicly available on registry
November 8, 2016
CompletedStudy Start
First participant enrolled
February 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedNovember 21, 2023
November 1, 2023
3.6 years
September 26, 2016
November 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Disability-free survival
Disability-free survival as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire
3 months
Secondary Outcomes (13)
Disability-free survival
1 month
Quality of life as measured by EuroQoL questionnaire
1 month
Quality of life as measured by EuroQoL questionnaire
3 months
Patient Health Status
1 month
Patient Health Status
3 months
- +8 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONRoutine monitoring
Continuous wireless monitoring
EXPERIMENTALContinuous wireless monitoring
Interventions
Continuous wireless monitoring of vital signs
Eligibility Criteria
You may qualify if:
- Adult patients undergoing acute or elective major or intermediate surgery
- American Society of Anesthesiology (ASA) score of I to IV
You may not qualify if:
- Inability to give written and informed consent
- Refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Academic Medical Center, University of Amsterdam
Amsterdam, Netherlands
University Medical Center Utrecht (UMCU)
Utrecht, Netherlands
Related Publications (1)
Posthuma LM, Breteler MJM, Lirk PB, Nieveen van Dijkum EJ, Visscher MJ, Breel JS, Wensing CAGL, Schenk J, Vlaskamp LB, van Rossum MC, Ruurda JP, Dijkgraaf MGW, Hollmann MW, Kalkman CJ, Preckel B. Surveillance of high-risk early postsurgical patients for real-time detection of complications using wireless monitoring (SHEPHERD study): results of a randomized multicenter stepped wedge cluster trial. Front Med (Lausanne). 2024 Jan 5;10:1295499. doi: 10.3389/fmed.2023.1295499. eCollection 2023.
PMID: 38249988DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benedikt Preckel, MD
Academic Medical Centyer Amsterdam, Anesthesiology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Anesthesiology
Study Record Dates
First Submitted
September 26, 2016
First Posted
November 8, 2016
Study Start
February 2, 2018
Primary Completion
August 31, 2021
Study Completion
August 31, 2021
Last Updated
November 21, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share