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NCT Number: NCT05129930

Fluid Overload and Pulmonary Function

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.

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Key information

Conditions

Water-Electrolyte Imbalance Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Critical Illness Digestive System Abnormalities Digestive System Diseases Disease Attributes Esophageal Atresia Esophageal Diseases Gastrointestinal Diseases Intensive Care Units Length of Stay Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

1 month–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

N.F. Filatov Childrens city hospital

Moscow, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. duration of intensive care unit (ICU) stay

    Time frame: up to 30 days after the surgery

    number of days in ICU after surgery before discharge

  2. duration of mechanical ventilation (MV)

    Time frame: up to 30 days after the surgery

    number of days of MV after surgery before switching to continuous positive airway pressure (CPAP)

  3. intraoperative fluid overload (IVF)

    Time frame: during the surgery

    ((injected fluid (ml) - diuresis (ml) - blood loss (ml))/weight before surgery)*100%

  4. fluid overload (FO) on the first postoperative day in the ICU

    Time frame: during the first postoperative day, exclude intraoperative period

    ((injected fluid (ml)-lost fluid (ml))/weight before admission to ICU)*100%

  5. total fluid overload on the first postoperative day

    Time frame: during the first postoperative day, include intraoperative period

    ((injected fluid (ml) - lost fluid (ml))/weight before surgery)*100%

  6. Fraction of Inspired Oxygen (FiO2)

    Time frame: in the the first postoperative day

    Fraction of Inspired Oxygen (FiO2)

  7. Fraction of Inspired Oxygen (FiO2)

    Time frame: in the second postoperative day

    Fraction of Inspired Oxygen (FiO2)

  8. Fraction of Inspired Oxygen (FiO2)

    Time frame: in the third postoperative day

    Fraction of Inspired Oxygen (FiO2)

  9. Oxygen saturation (Sp02)

    Time frame: in the first postoperative day

    Oxygen saturation (Sp02)

  10. Oxygen saturation (Sp02)

    Time frame: in the second postoperative day

    Oxygen saturation (Sp02)

  11. Oxygen saturation (Sp02)

    Time frame: in the third postoperative day

    Oxygen saturation (Sp02)

  12. Venous oxygen saturation (Svo2)

    Time frame: in the first postoperative day

    Venous oxygen saturation (Svo2)

  13. Venous oxygen saturation (Svo2)

    Time frame: in the second postoperative day

    Venous oxygen saturation (Svo2)

  14. Venous oxygen saturation (Svo2)

    Time frame: in the third postoperative day

    Venous oxygen saturation (Svo2)

  15. partial pressure of carbon dioxide (pC02)

    Time frame: in the first postoperative day

    partial pressure of carbon dioxide (pC02)

  16. partial pressure of carbon dioxide (pC02)

    Time frame: in the second postoperative day

    partial pressure of carbon dioxide (pC02)

  17. partial pressure of carbon dioxide (pC02)

    Time frame: in the third postoperative day

    partial pressure of carbon dioxide (pC02)

  18. inspiratory pressure (Pin)

    Time frame: in the first postoperative day

    inspiratory pressure (Pin)

  19. inspiratory pressure (Pin)

    Time frame: in the second postoperative day

    inspiratory pressure (Pin)

  20. inspiratory pressure (Pin)

    Time frame: in the third postoperative day

    inspiratory pressure (Pin)

  21. Positive end-expiratory pressure (PEEP)

    Time frame: in the first postoperative day

    Positive end-expiratory pressure (PEEP)

  22. Positive end-expiratory pressure (PEEP)

    Time frame: in the second postoperative day

    Positive end-expiratory pressure (PEEP)

  23. Positive end-expiratory pressure (PEEP)

    Time frame: in the third postoperative day

    Positive end-expiratory pressure (PEEP)

  24. duration of ICU stay corrected to sedation

    Time frame: up to 30 days after the surgery

    duration of ICU stay corrected for the duration of sedation

  25. duration of MV corrected to sedation

    Time frame: up to 30 days after the surgery

    duration of MV corrected for the duration of sedation

Sponsors and collaborators

Lead sponsor

Pirogov Russian National Research Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 22, 2021
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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