Fluid Overload and Pulmonary Function

Completed

• Conditions: Pediatric; Water-Electrolyte Imbalance; Intensive Care Units; Critical Illness; Length of Stay; Respiratory Failure; Esophageal Atresia

• Registration Number: NCT05129930
• Lead Sponsor: Pirogov Russian National Research Medical University

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.

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12-01
• Primary Completion: 2021-02-20
• Study Completion: 2021-05-01
• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-11-11
• Last Update Submitted: 2021-11-11
• Study First Posted: 2021-11-22
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
duration of intensive care unit (ICU) stay	up to 30 days after the surgery	number of days in ICU after surgery before discharge
intraoperative fluid overload (IVF)	during the surgery	((injected fluid (ml) - diuresis (ml) - blood loss (ml))/weight before surgery)\*100%
Fraction of Inspired Oxygen (FiO2)	in the third postoperative day	Fraction of Inspired Oxygen (FiO2)
duration of ICU stay corrected to sedation	up to 30 days after the surgery	duration of ICU stay corrected for the duration of sedation
duration of mechanical ventilation (MV)	up to 30 days after the surgery	number of days of MV after surgery before switching to continuous positive airway pressure (CPAP)
fluid overload (FO) on the first postoperative day in the ICU	during the first postoperative day, exclude intraoperative period	((injected fluid (ml)-lost fluid (ml))/weight before admission to ICU)\*100%
partial pressure of carbon dioxide (pC02)	in the third postoperative day	partial pressure of carbon dioxide (pC02)
total fluid overload on the first postoperative day	during the first postoperative day, include intraoperative period	((injected fluid (ml) - lost fluid (ml))/weight before surgery)\*100%
Oxygen saturation (Sp02)	in the third postoperative day	Oxygen saturation (Sp02)
inspiratory pressure (Pin)	in the third postoperative day	inspiratory pressure (Pin)
Positive end-expiratory pressure (PEEP)	in the third postoperative day	Positive end-expiratory pressure (PEEP)
duration of MV corrected to sedation	up to 30 days after the surgery	duration of MV corrected for the duration of sedation
Venous oxygen saturation (Svo2)	in the third postoperative day	Venous oxygen saturation (Svo2)

Trial Locations

Locations (1)

N.F. Filatov Childrens city hospital; 🇷🇺 Moscow, Russian Federation