Follow-up of Oncology Patients After Hospitalization in ICU (SALTO)

January 12, 2021 updated by: Assistance Publique - Hôpitaux de Paris

"Purpose: The overall prognosis of oncology patients admitted to intensive care has improved greatly in recent years, leading to a wider admission policy. Due to a decrease in mortality in intensive care, more and more patients returning oncological circuit for the continuation of treatment of the underlying disease The existence of sequelae after the ICU (Intensive Care Unit) stay, whether renal, cardiac, respiratory or other, may influence the continuation of the optimal anti -cancer treatments and thus reduce the chances of recovery or evolution without tumor progression. However, no studies have evaluated the effects of resuscitation on subsequent cancer treatment strategies. It would thus become better appreciate the long-term oncology patients discharged alive from the hospital after a stay in intensive care.

Main purpose of research :

Assess the feasibility of a anti-tumor therapy for patients with progressive solid tumors, after an intensive care stay for other reason than elective surgery monitoring or securing an invasive procedure. The possibility of making an anti -cancer treatment will be evaluated by the treating oncologist and classified total, partial or absent from that defined before or during the ICU stay

Secondary objective of the research :

Evaluate the percentage of patients discharged alive from the ICU and dying in the hospital.

Evaluate survival, lifestyle and physical and psychological effects of these patients after discharge from the hospital over a period of one year. It is understood that all these secondary endpoints will interfere with the existence of an evolutionary neoplasia not only with the ICU stay. They will therefore be interpreted with caution.

Study Type: observational Study Design: Prognostic study of routine care, national, prospective, cohort type "

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

"Nature of evaluated care: Longitudinal follow-up of post- resuscitation intensive care Concerned population: adult patients with active solid tumor out alive from the ICU and following-up in oncology in the same hospital as the resuscitator investigator.

Main objective: Measure the influence of ICU for patients with solid cancers to continue with optimal anti -cancer treatment, defined before or during hospitalization in intensive care.

Secondary objective: Assess the physical and psychological consequences of ICU stay of patients Evaluation criteria : Primary endpoint: proportion of patients living, out from ICU and hospital, can receive optimal cancer treatment later.

Research Methodology : Prognostic study of routine care, national, prospective, cohort type."

Study Type

Observational

Enrollment (Actual)

309

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Montfermeil, France, 93370
        • CHI Le Raincy-Montfermeil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult patients with active solid tumor out alive from the ICU and monitoring in oncology in the same hospital as the resuscitator investigator.

Description

Inclusion criteria:

  • Patient with progressive solid tumor hospitalized in intensive care and got out alive
  • Oncology patients followed in the same hospital as the investigator resuscitator
  • Age ≥ 18 years
  • Affiliate of social insurance
  • Agree to participate

Exclusion criteria :

  • Patient hospitalized for programed surgery
  • Hospitalization for securing procedure
  • Pregnancy or breastfeeding woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with cancer admitted in ICU who will be eligible for optimal anti-cancer treatment after discharge from ICU
Time Frame: Months12
Months12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 17, 2019

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

March 20, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • KI120906
  • 2013-A00683-42 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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