Clinical Trials Directory

Trials / Completed

CompletedNCT05129930

Fluid Overload and Pulmonary Function

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

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Pirogov Russian National Research Medical University · Academic / Other
Sex
All
Age
1 Month – 3 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2020-12-01
Primary completion
2021-02-20
Completion
2021-05-01
First posted
2021-11-22
Last updated
2021-11-22

Locations

1 site across 1 country: Russia

Source: ClinicalTrials.gov record NCT05129930. Inclusion in this directory is not an endorsement.