Pathophysiology of Anemia in PICU Survivors

NCT05693194 | Unknown

• 1 other identifier: 2019-2200
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

In 2007, the TRIPICU trial which demonstrated the safety of tolerating anemia in critically ill children through avoidance of unnecessary red cell transfusions. This landmark study led to practice changes and a reduction in the use of red cell transfusion during PICU stay. However, although this restrictive approach appears safe in the acute setting of PICU, there is a paucity of data regarding its long-term impact on the burden of anemia at discharge. Although 98% of patients now survive their PICU stay, we and other groups have documented that around 50% of PICU admissions will be anemic at discharge. A major contributing factor may be the increasing adoption of restrictive red cell transfusion policies during the phase of ICU admission. Given that there are approximately 9000 PICU admissions/year in Canada, this represents almost 4500 children are discharged with anemia. The causes of anemia are multifactorial, including inflammation, co-morbidities and nutritional, including iron depletion. Anemia, in particular iron deficiency anemia, is well recognized to be associated with abnormal neurocognitive development in infants and young children. Anemia can also contribute to lower exercise tolerance levels impeding children's development and quality of life. This protocol describes a prospective observational cohort study of PICU survivors, to better understand the epidemiology of anemia at and after PICU discharge. The primary aim will be to determine the prevalence of anemia at 2 months after PICU discharge (primary aim) as well as at 6 and 12 months follow-up (secondary aim). We will evaluate the association of anemia with neurocognitive dysfunction, and quality of life (secondary aim). We will also investigate the pathophysiology of anemia after PICU discharge. We will perform blood tests on anemic patients to measure inflammatory markers as well as markers of iron deficiency (including the new biomarker hepcidin) (tertiary aim).All patients included will be followed while hospitalized in the PICU, as well as at dedicated clinics at 2, 6, and 12 months after PICU discharge. Anemia affects a large proportion of PICU survivors. This study will allow us to better understand the long-term prevalence and causes of anemia in this population as well as potential association with long-term outcome. Anemia (specifically iron responsive anemia) could be a potentially readily modifiable risk factor, to improve the long-term well-being of these children.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Prevalence of anemia at 2 months post PICU discharge

  we will measure peripheral blood count, which includes a hemoglobin concentration, in all patients at PICU discharge and at 2 months follow-up in patients found to be anemic at PICU discharge.

  2 months

Secondary Outcomes (6)

• Prevalence of anemia at 6 months and 12 months post PICU discharge

  12 months

• The association between post-PICU anemia and neurocognitive outcome at 2, 6, 12 months after PICU discharge.

  12 months

• The association of post-PICU anemia with quality of life at 2, 6, 12 months after PICU discharge.

  12 months

• The etiology of anemia, by determining the blood levels of iron, transferrin, proportion of transferrin saturation, blood concentration of inflammatory markers - interleukin-6(IL-6), C-reactive protein and erythropoietin

  12 months

• The PICU risks factors associated with post-PICU anemia

  12 months

Eligibility Criteria

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

Study Population

The purpose of these inclusion criteria is to enrol sicker children with significant critical illness and exclude "healthier" children who are admitted to PICU for monitoring and observation (intoxication, post-operative pain management, etc.).

You may qualify if:

• \) are \<18 years; AND 2) have a PICU length of stay at least 4 days; AND 3) required invasive mechanical ventilation ≥ 48 hours

You may not qualify if:

• we excluded children with 1) pre-existing hematologic disorder causing anemia, including treatment with immunosuppressant or cytotoxic drugs; 2) acute or chronic renal failure requiring renal replacement therapy at time of PICU admission; and 3) postoperative cardiac surgery. The local Institutional Review Board approved this study (#2019-2200).

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

Hopital Ste-Justine

Montreal, Quebec, H2V2Y4, Canada

RECRUITING

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Geneviève Du Pont-Thibodeau, MD,MSc

  Centre Hospitalier universitaire Sainte-Justine (CHUSJ)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saly El Salti, MSc

CONTACT

5143454931; saly.elsalti@recherche-ste-justine.qc.ca

Lucy Clayton, MSc

CONTACT

5143454931; lucy.clayton@recherche-ste-justine.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric intensivist, MD, MSc, Associate Clinical Professor

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: January 20, 2023
• Study Start: October 3, 2019
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)