Frailty Prevalence in Surgical European Patients. Europea... | NCT04140370

Studies
Frailty Prevalence in Surgical European Patients. European Prospective Cohort Stufy of the Prevalence of Frailty in Surgical Patients.

NCT04140370

Sponsor

Hospital Clinic of Barcelona

Status

Unknown status

Last Update Posted

Oct 25, 2019Actual

Enrollment

6,500Estimated

Phase

Not provided

Conditions

Frailty

Interventions

There is no intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2020Estimated

Primary Completion Date

Aug 15, 2020Estimated

Completion Date

Dec 15, 2020Estimated

First Submitted Date

Oct 18, 2019

First Submission Date that Met QC Criteria

Oct 24, 2019

First Posted Date

Oct 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2019

Last Update Posted Date

Oct 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carlos Ferrando Ortolá, Head of Surgical Intensive Care Unit, Hospital Clinic of BarcelonaPrincipal Investigator

Lead Sponsor

Hospital Clinic of BarcelonaOTHER

Collaborators

Name	Class
Spanish Multimodal Rehabilitation Group	UNKNOWN
Spanish Sociey of Anesthesiology	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6,500Estimated

Name	Type	Description	Arm Group Labels	Other Names
There is no intervention	Other	There is no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carlos Ferrando, MD	Contact	+34 932275400	2890	cmferrando@clinic.cat
Sara Darriba	Contact	+34 932275400	2890	darriba@clinic.cat

Overall Officials

Name	Affiliation	Role
César Aldecoa, MD	Hospital Río Ortega	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000073496	Frailty

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided