Impact of Age on the Pulmonary Renin-Angiotensin System in Acute Respiratory Distress Syndrome

Impact of Age on the Pulmonary Renin-Angiotensin System in Acute Respiratory Distress Syndrome - Age and ARDS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41340

Enrollment

120

Registered

2012-12-18

Start date

2013-05-25

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute respiratory distress syndrome (ARDS)

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: •Signed informed consent by the parents or legal caretakers. •Admitted to the neonatal intensive care unit (NICU) or pediatric intensive care unit (PICU) of the Emma Children*s Hospital, Academic Medical Center of Amsterdam, the Netherlands. •Intubated and mechanically ventilated, with an anticipated duration of mechanical ventilation of at least 48 hours at enrolment (as judged by the investigator or the neonatologist on duty). •Enrolment within 24 hours after the start of mechanical ventilation. •Body weight of 1 kg or more at the time of enrolment. •Two or more of the following criteria at the time of enrolment: o Hypothermia ( 38.0 °C), or body temperature instability. o Bradycardia or tachycardia, according to age, or a prolonged capillary refill time. o Leukopenia or leucocytosis, according to age, or more than 10 % banded neutrophils. o Tachypneu or apneu*s, according to age, or cyanosis

Exclusion criteria

Exclusion criteria: •Neonates with a postconceptual age less than 32 weeks within 1 week post partum. •Immune compromised; chronic respiratory failure, neuromuscular diseases, cyanotic congenital heart disease or signs of cardiogenic pulmonary edema, severe congenital pulmonary abnormalities. •(Previous) use of medication which intervene with the RAS •Previous mechanical ventilation, surfactant or NO-therapy within 1 week before eligibility for enrolment into the study. •Longer than 48 hours antibiotics previous to IC-admission.

Design outcomes

Primary

Measure	Time frame
The main study parameters are the different RAS components measured in bronchoalveolare lavage fluid (BALF) and blood at different time points.	—

Secondary

Measure	Time frame
- Effector molecules of the pulmonary RAS (including cytokines, compoments of coagulation and fibrotic components) - Oxygenation index (OI); alveolar-arterial oxygen difference (DD(A-a)O2); PaO2/FIO2 ratio - Score for Neonatal Acute Physiology II (SNAPII) or pediatric risk of mortality score (PRISM). - Ventilator-free days (VFDs) - Bronchopulmonary dysplasia (BPD) - Mortality: within 60 days after study enrolment	—

Measure

Time frame

- Effector molecules of the pulmonary RAS (including cytokines, compoments of coagulation and fibrotic components) - Oxygenation index (OI); alveolar-arterial oxygen difference (DD(A-a)O2); PaO2/FIO2 ratio - Score for Neonatal Acute Physiology II (SNAPII) or pediatric risk of mortality score (PRISM). - Ventilator-free days (VFDs) - Bronchopulmonary dysplasia (BPD) - Mortality: within 60 days after study enrolment

—

Countries

Netherlands

Outcome results