Clinical trial NCT05129930: Fluid Overload and Pulmonary Function
Official title: Fluid Overload and Pulmonary Function After Coloesophagoplasty in Children. Single-central Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Water-Electrolyte Imbalance
Intensive Care Units
Pediatric
Critical Illness
Length of Stay
Respiratory Failure
Esophageal Atresia
Keywords: Liquid
Liquid overload
Mechanical ventilation
Infant
Preschool Child
Respiratory failure
Coloesophagoplasty
Esophageal atresia
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 40 children with EA with/without TPF, aged from 1 month to 3 years, who underwent coloesophagoplasty at the N.F. Filatov Children city Hospital, Moscow, Russia, from December 1, 2017 to December 31, 2020.

Brief summary: Esophageal atresia is a rare but severe malformation, and it requires early surgery. Coloesophagoplasty is surgical repair of the esophageal with an isoperistaltic transverse colon graft. In the postoperative period after coloesophagoplasty children require careful monitoring of fluid balance, because clinically significant fluid overload can lead to dysfunction of various organs and systems.

Detailed description: Esophageal atresia (EA) is a defect of the embryogenesis of the laryngotracheal tube. There are isolated forms of EA and combinations with a tracheoesophageal fistula (TPF). Esophageal plastic surgery with an isoperistaltic transplant from the transverse colon was performed in children with EA. After this surgical intervention children require observation in the intensive care unit (ICU). During this period, infusion therapy satisfies physiological needs and compensates for physiological and pathological losses. However, it is not always possible to compensate for the body's fluid needs and maintain a normovolemic state. Thus, fluid overload develops. It is based on a pathophysiological process when severe operational stress leads to the damage of glycocalyx in the vascular wall. As a result, albumin freely passes into the interstitium, and oncotic pressure rises in tissues. Fluid overload in the intra- and postoperative period can be a factor in an unfavorable outcome, leading to organ damage, as well as death.

Eligibility criteria: Inclusion Criteria:

* Аge from 1 month to 3 years
* EA with / without
* Tracheoesophageal fistula (TPF)
* Сoloesophagoplasty.

Exclusion Criteria:

* Аesophageal burn,
* Oesophageal peptic stenosis,
* Congenital heart disease
* Cardiotonic support in the postoperative period
* Renal malformations
* Bacterial pneumonia in the postoperative period,
* Bronchopulmonary malformations.

Primary outcomes:
measure: duration of intensive care unit (ICU) stay
timeFrame: up to 30 days after the surgery
measure: duration of mechanical ventilation (MV)
timeFrame: up to 30 days after the surgery
measure: intraoperative fluid overload (IVF)
timeFrame: during the surgery
measure: fluid overload (FO) on the first postoperative day in the ICU
timeFrame: during the first postoperative day, exclude intraoperative period
measure: total fluid overload on the first postoperative day
timeFrame: during the first postoperative day, include intraoperative period
measure: Fraction of Inspired Oxygen (FiO2)
timeFrame: in the the first postoperative day
measure: Fraction of Inspired Oxygen (FiO2)
timeFrame: in the second postoperative day
measure: Fraction of Inspired Oxygen (FiO2)
timeFrame: in the third postoperative day
measure: Oxygen saturation (Sp02)
timeFrame: in the first postoperative day
measure: Oxygen saturation (Sp02)
timeFrame: in the second postoperative day
measure: Oxygen saturation (Sp02)
timeFrame: in the third postoperative day
measure: Venous oxygen saturation (Svo2)
timeFrame: in the first postoperative day
measure: Venous oxygen saturation (Svo2)
timeFrame: in the second postoperative day
measure: Venous oxygen saturation (Svo2)
timeFrame: in the third postoperative day
measure: partial pressure of carbon dioxide (pC02)
timeFrame: in the first postoperative day
measure: partial pressure of carbon dioxide (pC02)
timeFrame: in the second postoperative day
measure: partial pressure of carbon dioxide (pC02)
timeFrame: in the third postoperative day
measure: inspiratory pressure (Pin)
timeFrame: in the first postoperative day
measure: inspiratory pressure (Pin)
timeFrame: in the second postoperative day
measure: inspiratory pressure (Pin)
timeFrame: in the third postoperative day
measure: Positive end-expiratory pressure (PEEP)
timeFrame: in the first postoperative day
measure: Positive end-expiratory pressure (PEEP)
timeFrame: in the second postoperative day
measure: Positive end-expiratory pressure (PEEP)
timeFrame: in the third postoperative day
measure: duration of ICU stay corrected to sedation
timeFrame: up to 30 days after the surgery
measure: duration of MV corrected to sedation
timeFrame: up to 30 days after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: N.F. Filatov Childrens city hospital
Study officials:
affiliation: Pirogov Russian National Research Medical University
name: Sergey M Stepanenko, PhD, Prof.
role: STUDY_CHAIR
References: