The Critical Care Response to the COVID-19 Pandemic in Ma... | NCT04393324

Studies
The Critical Care Response to the COVID-19 Pandemic in Madrid

NCT04393324

Sponsor

Hospital San Carlos, Madrid

Status

Unknown status

Last Update Posted

May 28, 2020Actual

Enrollment

2,500Estimated

Phase

Not provided

Conditions

COVID-19
ARDS, Human

Interventions

Not provided

Countries

Spain

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

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2020Actual

Primary Completion Date

May 31, 2020Estimated

Completion Date

Jun 30, 2020Estimated

First Submitted Date

May 17, 2020

First Submission Date that Met QC Criteria

May 17, 2020

First Posted Date

May 19, 2020Actual

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

May 26, 2020

Last Update Posted Date

May 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Miguel Sanchez Garcia, Director Critical Care, Hospital San Carlos, MadridPrincipal Investigator

Lead Sponsor

Hospital San Carlos, MadridOTHER

Collaborators

Name	Class
FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS	OTHER

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

Description of the adaptation of ICUs in the region of Madrid to que surge in demand of critical care due to COVID-19

Detailed Description

Background

The worldwide SARS-CoV-2 pandemic has put healthcare systems under the extreme pressure, with intensive care units being faced with a previously unseen number of patients with severe respiratory failure requiring admission for endotracheal intubation and mechanical ventilation.

Methods

The study describes how the critical care resources adapted to the sudden surge of severe Covid-19 in the province of Madrid, which developed at the beginning of March 2020. The response consisted of a swift increase in ICU capacity and the relocation of patients. ICU beds were mounted outside the usual intensive care areas. Transfer of critically ill intubated patients with COVID-19 was managed in an instant messenger service group composed of representatives of 53 intensive care units and performed by the Madrid Emergency Medical Systems (EMS). The investigators will compare transferred with non-transferred patients matched for risk factors for cardiovascular and respiratory complications.

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

9 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transferred patients		A subgroup of Critically ill intubated patients with COVID-19 associated ARDS were transferred from overwhelmed ICUs to other with available free beds
Matched Non-transferred patients		A subgroup from the global cohort, matched for risk factors will be compared with transferred patients for outcome variables

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	ICU mortality	9 weeks

Secondary Outcomes

Measure	Description	Time Frame
Length of ICU stay	From admission to discharge or death	9 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admitted to ICU in Madrid with COVID-19

Exclusion Criteria:

Admitted to ICU without COVID-19

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Critically ill patients admitted to ICUs in Madrid for COVID-19

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Miguel S Sanchez Garcia, MD	Contact	+34913303223		miguelsanchez.hcsc@gmail.com
Antonio S Núñez Reiz	Contact	+34913303223		anunezreiz@gmail.com

Overall Officials

Name	Affiliation	Role
Miguel Sánchez García, MD	Hospital San Carlos, Madrid	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinico San Carlos	Recruiting	Madrid		28040	Spain

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided