CancerNCT01304680
Evaluation of Fluid Resuscitation in Children With Cancer With Severe Sepsis / Septic Shock
An observational study of Cancer and Septic Shock, run by Grupo de Apoio ao Adolescente e a Crianca com Cancer at 1 site in Brazil.
Trial summary
Retrospective study to evaluate the characteristics of patients and of fluid resuscitation during intensive care unit hospitalization of patients under septic chock. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Septic Shock, Other Fluid Overload
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: pediatric patients admitted to intensive care unit with septic chock
Who may be able to join
- patients admitted between Jan/2009 and Dec/2010
- patients with septic chock diagnosis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Grupo de Apoio ao Adolescente e a Criança com Cancer
São Paulo, São Paulo, 04023-062
About this study
Retrospective study to evaluate the characteristics of patients and of fluid resuscitation during intensive care unit hospitalization of patients under septic chock.
- Conditions
- Cancer, Septic Shock, Other Fluid Overload
- Medical subject headings
- Neoplasms, Shock, Septic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo de Apoio ao Adolescente e a Crianca com Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priscila de Biasi, Grupo de Apoio ao Adolescente e a Crianca com Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304680
- Sponsor's protocol ID
- UTI/IOP 03/11
- Other IDs
- 0101/11
- Status last verified
- Nov 2012
- First submitted
- 24 Feb 2011
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fluid Resuscitation in Children With Cancer With Severe Sepsis / Septic Shock
- ClinicalTrials.gov ID
- NCT01304680
- Acronym / sponsor ID
- UTI/IOP 03/11
- Conditions
- Cancer, Septic Shock, Other Fluid Overload
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Grupo de Apoio ao Adolescente e a Crianca com CancerUniversity, hospital or other
- Study start
- Jan 2011
- First posted
- 25 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective study to evaluate the characteristics of patients and of fluid resuscitation during intensive care unit hospitalization of patients under septic chock.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pediatric patients admitted to intensive care unit with septic chock
Key inclusion criteria (2 listed)
- patients admitted between Jan/2009 and Dec/2010
- patients with septic chock diagnosis
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Septic Shock, run by Grupo de Apoio ao Adolescente e a Crianca com Cancer at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Priscila de Biasi, MD (55-11-5080-8400, pribiasi@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2012.