Prospective Evaluation of the Incidence of PICS

NCT03584399 | Terminated

• 1 other identifier: 1802247905
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Advances in modern medicine and critical care interventions have greatly impacted survival of critically ill patients, but these interventions are not without consequences. Although patients may now survive the initial critical illness, these patients may not recover to their pre-illness baseline state of health. Recent data in both the critically ill adult and neonatal patients who survive sepsis or surgical events have been shown to progress to persistent inflammatory, immunosuppressed, catabolic syndrome (PICS). This was first identified in adult trauma patients, and more recently was defined in critically ill neonates. To date, there are no published reports of PICS in the critically ill pediatric population. Our long-term goal is to understand PICS in the pediatric population and how early medical and nutritional interventions may impact overall morbidity and survival. To achieve this goal first PICS must first be characterized in the pediatric population. The hypothesis is that PICS occurs in pediatric patients and is associated with increased time to return to a baseline functional life post-injury or illness. The hypothesis will be tested by pursuing the following specific aims. Specific Aim 1: To determine the incidence of PICS in the pediatric population and associate the diagnosis of PICS to survival and time to return to baseline functional life and Specific Aim 2: To determine if early increased inflammatory and immunosuppressive markers are associated with the development of PICS and increased morbidity and mortality. These aims will be accomplished by conducting a prospective single-center observational pilot study to enroll pediatric patients with an anticipated pediatric intensive care unit (PICU) stay greater than 14 days. Through these two aims, the investigators anticipate that this research will provide an explanation into the interplay of inflammation, immunosuppression, and catabolism in critically ill children, which is imperative to the development of early therapeutic and nutritional interventions that can reduce morbidity and mortality associated with critical illness.

Conditions

Metabolism and Nutrition Disorder

Outcome Measures

Primary Outcomes (1)

• Occurrence of PICS in the pediatric critical care population

  Diagnosis of PICS will be determined when a patient has been admitted to the PICU for \>14 days and has signs of both inflammation (CRP \>15mg/L) and immunosuppression (total lymphocyte count \< 0.80×109/L), as well as catabolism (Serum albumin \< 3.0g/dL, Prealbumin \<10mg/dL, Retinol binding protein \<10μg/dL, and weight loss \>10% or body mass index \<18 during hospitalization).

  July 1, 2018 to June 30, 2019

Secondary Outcomes (1)

• Mortality

  July 1, 2018 to June 30 2019

Interventions

PICS in critically ill pediatric population OTHER

Collection of additional blood sample from those subjects meeting criteria for the study.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects will be admitted the to pediatric intensive care unit of Riley Hospital for Children.

You may qualify if:

• Patients who are \< or = to 18 years of age and have an anticipated length of PICU stay of \> or = to 14 days from June 1, 2018 through January 31, 2019

You may not qualify if:

• Chronic mechanical ventilation, Known chronic inflammatory disease process, or Diagnosed with failure to thrive or malnutrition upon admission to the PICU

Sponsors & Collaborators

• Indiana University: lead
• American Society for Parenteral and Enteral Nutrition: collaborator

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Related Publications (5)

• Epstein D, Brill JE. A history of pediatric critical care medicine. Pediatr Res. 2005 Nov;58(5):987-96. doi: 10.1203/01.PDR.0000182822.16263.3D. Epub 2005 Sep 23.

  PMID: 16183804 BACKGROUND

• Marshall JC. Critical illness is an iatrogenic disorder. Crit Care Med. 2010 Oct;38(10 Suppl):S582-9. doi: 10.1097/CCM.0b013e3181f2002a.

  PMID: 21164401 BACKGROUND

• Gentile LF, Cuenca AG, Efron PA, Ang D, Bihorac A, McKinley BA, Moldawer LL, Moore FA. Persistent inflammation and immunosuppression: a common syndrome and new horizon for surgical intensive care. J Trauma Acute Care Surg. 2012 Jun;72(6):1491-501. doi: 10.1097/TA.0b013e318256e000.

  PMID: 22695412 BACKGROUND

• Vanzant EL, Lopez CM, Ozrazgat-Baslanti T, Ungaro R, Davis R, Cuenca AG, Gentile LF, Nacionales DC, Cuenca AL, Bihorac A, Leeuwenburgh C, Lanz J, Baker HV, McKinley B, Moldawer LL, Moore FA, Efron PA. Persistent inflammation, immunosuppression, and catabolism syndrome after severe blunt trauma. J Trauma Acute Care Surg. 2014 Jan;76(1):21-9; discussion 29-30. doi: 10.1097/TA.0b013e3182ab1ab5.

  PMID: 24368353 BACKGROUND

• Ellis N, Hughes C, Mazurak V, Joynt C, Larsen B. Does Persistent Inflammatory Catabolic Syndrome Exist in Critically Ill Neonates? JPEN J Parenter Enteral Nutr. 2017 Nov;41(8):1393-1398. doi: 10.1177/0148607116672621. Epub 2016 Oct 10.

  PMID: 27875283 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

In addition to CRP and TLC, which will be collected at 14 days (± 1 day) of PICU admission , an additional blood samples will be collected at these time points to be frozen for further analysis. At the time of blood collection, an additional 5 mL of blood will be collected, processed, and stored at -80 degree Celsius. Once desired time-points are identified and further funding obtained, samples will be processed in batches to evaluate biochemical markers of inflammation. This will be performed using The Inflammatory Cytokine Human Magnetic 5-Plex Panel for the Luminex™ platform. This will quantify GM-CSF, IL-1β, IL-6, IL-8 and TNF-α in serum samples.

MeSH Terms

Conditions

Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Courtney M Rowan, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Pediatrics

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 12, 2018
• Study Start: March 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)