Fluid Overload and Pulmonary Function

Critical Illness Clinical Trial

Official title:

Fluid Overload and Pulmonary Function After Coloesophagoplasty in Children. Single-central Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05129930
• Other study ID #: FO-Coloesopfagoplasty
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: December 2020
• Source: Pirogov Russian National Research Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 1, 2021
• Est. primary completion date: February 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 3 Years

Eligibility

Inclusion Criteria:

• ?ge from 1 month to 3 years
• EA with / without
• Tracheoesophageal fistula (TPF)
• ?oloesophagoplasty.

Exclusion Criteria:

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Russian Federation	N.F. Filatov Childrens city hospital	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

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