Fluid Overload and Pulmonary Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Liquid Liquid overload Mechanical ventilation Infant Preschool Child Respiratory failure Coloesophagoplasty Esophageal atresia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sergey M Stepanenko, PhD, Prof.

Role: STUDY_CHAIR

Pirogov Russian National Research Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

N.F. Filatov Childrens city hospital

Moscow, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FO-Coloesopfagoplasty

Identifier Type: -

Identifier Source: org_study_id