NCT04140370

Brief Summary

European prospective one day cohort study. Analysis of the prevalence of frailty and predefined 30-day postoperative complications in adult patients undergoing emergency or elective surgery.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

April 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

October 18, 2019

Last Update Submit

October 24, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients with frailty identified in the preoperative assessment in both elective and emergency surgery, as well as frailty's severity.

    30 days

Interventions

There is no intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who will undergo emergency or elective surgery with an intended hospital stay of more than 24 hours and any type of anesthesia.

You may qualify if:

  • Patients over the age of 18 who will undergo emergency or elective surgery with an intended hospital stay of more than 24 hours and any type of anesthesia.

You may not qualify if:

  • Outpatient (ie. day case) surgery, obstetric analgesia or anesthesia, organ transplant surgery, cardiac surgery, neurosurgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • César Aldecoa, MD

    Hospital Río Ortega

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Ferrando, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Surgical Intensive Care Unit

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 25, 2019

Study Start

April 15, 2020

Primary Completion

August 15, 2020

Study Completion

December 15, 2020

Last Updated

October 25, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share