LymphopeniaNCT02698683
Lymphocyte Count as a Sign of Immunoparalysis and Its Correlation With Nutritional Status in Septic Pediatric Patients
An observational study of Lymphopenia, run by University of Sao Paulo.
Trial summary
Participants were classified as normal or malnourished according to anthropometric measures. Serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. Lymphocyte count was also recorded on the 1st and 7th days. Read more about this study
- Who is it for?
- Ages 1 month to 14 years
- Conditions the study is for
- Lymphopenia
- What is being tested?
- lymphocyte count
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Jan 2016
- 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 1 month to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric septic patients
Who may be able to join
- septic patients
Who cannot join
- -
About this study
Official title: Lymphocyte Count as a Sign of Immunoparalysis and Its Correlation With Nutritional Status in Septic Pediatric Intensive Care Patients: A Pilot Study
Participants were classified as normal or malnourished according to anthropometric measures. Serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. Lymphocyte count was also recorded on the 1st and 7th days.
Read the detailed description
The investigators enrolled 14 consecutive patients with sepsis. Patients were classified as normal or malnourished according to anthropometric measures. As an additional evaluation of nutritional status, serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. Lymphocyte count was also recorded on the 1st and 7th days. Investigators correlated nutritional status with lymphocyte count and zinc dosage.
- Conditions
- Lymphopenia
- Being tested
- lymphocyte count
- Keywords
- Nutrition, Lymphocyte Count, Immunoparalysis, nutritional status of septic patients
- Medical subject headings
- Lymphopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphocyte countOther
lymphocyte count
| Study group | Role | What they receive |
|---|---|---|
| malnourished | low zinc, low albumin, anthropometric measures lower than percentile 5 lymphocyte count Receives: Other: lymphocyte count | |
| well nourished | normal zinc, normal albumin, anthropometric measures higher than percentile 5 lymphocyte count Receives: Other: lymphocyte count |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of lymphopenia
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startFeb 2014
- Primary completionJun 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LymphopeniaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talita Freitas Manzoli, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698683
- Sponsor's protocol ID
- 2015-LCSINS
- Status last verified
- Feb 2016
- First submitted
- 22 Feb 2016
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: there is no plan to share data
Publications
Delgado AF, Okay TS, Leone C, Nichols B, Del Negro GM, Vaz FA. Hospital malnutrition and inflammatory response in critically ill children and adolescents admitted to a tertiary intensive care unit. Clinics (Sao Paulo). 2008 Jun;63(3):357-62. doi: 10.1590/s1807-59322008000300012.
PubMed 18568246Manzoli TF, Delgado AF, Troster EJ, de Carvalho WB, Antunes AC, Marques DM, Zamberlan P. Lymphocyte count as a sign of immunoparalysis and its correlation with nutritional status in pediatric intensive care patients with sepsis: A pilot study. Clinics (Sao Paulo). 2016 Nov 1;71(11):644-649. doi: 10.6061/clinics/2016(11)05.
PubMed 27982165
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphocyte Count as a Sign of Immunoparalysis and Its Correlation With Nutritional Status in Septic Pediatric Intensive Care Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT02698683
- Acronym / sponsor ID
- 2015-LCSINS
- Conditions
- Lymphopenia
- Keywords
- Nutrition, Lymphocyte Count, Immunoparalysis, nutritional status of septic patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Mar 2016 (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.
Participants were classified as normal or malnourished according to anthropometric measures. Serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. Lymphocyte count was also recorded on the 1st and 7th days.
Detailed description
The investigators enrolled 14 consecutive patients with sepsis. Patients were classified as normal or malnourished according to anthropometric measures. As an additional evaluation of nutritional status, serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. Lymphocyte count was also recorded on the 1st and 7th days. Investigators correlated nutritional status with lymphocyte count and zinc dosage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| malnourished | – | Other: lymphocyte countlow zinc, low albumin, anthropometric measures lower than percentile 5 lymphocyte count |
| well nourished | – | Other: lymphocyte countnormal zinc, normal albumin, anthropometric measures higher than percentile 5 lymphocyte count |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric septic patients
Key inclusion criteria (1 listed)
- septic patients
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lymphocyte countlymphocyte count | Other | malnourished, well nourished |
Primary outcome
presence of lymphopenia
Time frame: seven days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- Results publication: PubMed 18568246Delgado AF, Okay TS, Leone C, Nichols B, Del Negro GM, Vaz FA. Hospital malnutrition and inflammatory response in critically ill children and adolescents admitted to a tertiary intensive care unit. Clinics (Sao Paulo). 2008 Jun;63(3):357-62. doi: 10.1590/s1807-59322008000300012.
- Derived from this study: PubMed 27982165Manzoli TF, Delgado AF, Troster EJ, de Carvalho WB, Antunes AC, Marques DM, Zamberlan P. Lymphocyte count as a sign of immunoparalysis and its correlation with nutritional status in pediatric intensive care patients with sepsis: A pilot study. Clinics (Sao Paulo). 2016 Nov 1;71(11):644-649. doi: 10.6061/clinics/2016(11)05.
- Individual participant dataSharing planned: No. there is no plan to share data
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphopenia, run by University of Sao Paulo.
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 1 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: finished, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of lymphopenia (time frame: seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02698683, which also lists 2 linked publications.
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 4 Mar 2016.