Lymphocyte Count as a Sign of Immunoparalysis and Its Correlation With Nutritional Status in Septic Pediatric Patients

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT02698683
• Collaborator: (none)
• Enrollment: 14
• Duration (Months): 23

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphopenia	Other: lymphocyte count

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

• Study Type: Observational
• Actual Enrollment: 14 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Lymphocyte Count as a Sign of Immunoparalysis and Its Correlation With Nutritional Status in Septic Pediatric Intensive Care Patients: A Pilot Study
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
malnourished low zinc, low albumin, anthropometric measures lower than percentile 5 lymphocyte count	Other: lymphocyte count; lymphocyte count
well nourished normal zinc, normal albumin, anthropometric measures higher than percentile 5 lymphocyte count	Other: lymphocyte count; lymphocyte count

Outcome Measures

Primary Outcome Measures

1. presence of lymphopenia [seven days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• septic patients

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Talita Freitas Manzoli, Medical doctor, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT02698683
• Other Study ID Numbers: 2015-LCSINS
• First Posted: Mar 4, 2016
• Last Update Posted: Mar 4, 2016
• Last Verified: Feb 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Talita Freitas Manzoli, Medical doctor, University of Sao Paulo: Nutrition; Lymphocyte Count; Immunoparalysis; nutritional status of septic patients
• Additional relevant MeSH terms: Lymphopenia

Study Results

No Results Posted as of Mar 4, 2016