NCT04887220

Brief Summary

COVID-19 infection produces thousands of hospital admissions in a very short period of time, including critical care patients. It is expected that those who survive a severe spectrum of the disease, will present some degree of health decline in the medium and long term, becoming chronic patients. Post-intensive care syndrome (PICS) was described by the Society of Critical Care Medicine (SCCM) as a new altered or worsening of physical, cognitive, or mental condition due to critical illness and persisting after hospitalization, including pain. Also, clinical features of infection include different types of pain, and if this pain persists, it can turn into a chronic condition. Chronic pain is a currently recognized disease, but under-treated in many cases, generating a significant deterioration in the quality of life of this patient. It is vitally important to generate early care circuits to detect and treat those expected complications, such as chronic pain in these patients. The objective of this study is to estimate the level of persistent pain and its impact on health-related quality of life after admission to an intensive care unit in patients who suffered this infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 21, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

January 21, 2021

Last Update Submit

March 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • VAS scale value

    Chronic pain in PostICU COVID19 survivors, measured by VAS scale from Brief Pain Inventory Questionnaire

    1 year

Secondary Outcomes (3)

  • Quality of life score

    1 year

  • ID Pain test value

    1 year

  • HAD scale value

    1 year

Eligibility Criteria

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

Adults survivors after critical state of COVID 19, who requires critical care.

You may qualify if:

  • Post ICU COVID 19 Survivor
  • Adult 18 year or older, who gives its approval to participate

You may not qualify if:

  • Refusal to participate
  • Neurological or physical secuale, disabled to answer a questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2021

First Posted

May 14, 2021

Study Start

February 15, 2021

Primary Completion

May 31, 2022

Study Completion

March 1, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations