Water-Electrolyte ImbalanceNCT05129930
Fluid Overload and Pulmonary Function
An observational study of Water-Electrolyte Imbalance and Intensive Care Units, run by Pirogov Russian National Research Medical University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 1 month to 3 years
- Conditions the study is for
- Water-Electrolyte Imbalance, Intensive Care Units, Pediatric
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 1 Dec 2020to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: 40 children with EA with/without TPF, aged from 1 month to 3 years, who underwent coloesophagoplasty at the N.F. Filatov Children city Hospital, Moscow, Russia, from December 1, 2017 to December 31, 2020.
Who may be able to join
- Аge from 1 month to 3 years
- EA with / without
- Tracheoesophageal fistula (TPF)
- Сoloesophagoplasty.
Who cannot join
- Аesophageal burn,
- Oesophageal peptic stenosis,
- Congenital heart disease
- Cardiotonic support in the postoperative period
- Renal malformations
- Bacterial pneumonia in the postoperative period,
- Bronchopulmonary malformations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluid Overload and Pulmonary Function After Coloesophagoplasty in Children. Single-central Observational Study
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.
Read the 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
- Water-Electrolyte Imbalance, Intensive Care Units, Pediatric, Critical Illness, Length of Stay, Respiratory Failure
- Keywords
- Liquid, Liquid overload, Mechanical ventilation, Infant, Preschool Child, Respiratory failure, Coloesophagoplasty, Esophageal atresia
- Medical subject headings
- Water-Electrolyte Imbalance, Critical Illness, Respiratory Insufficiency, Esophageal Atresia
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of intensive care unit (ICU) stay
number of days in ICU after surgery before discharge
Measured: up to 30 days after the surgery
duration of mechanical ventilation (MV)
number of days of MV after surgery before switching to continuous positive airway pressure (CPAP)
Measured: up to 30 days after the surgery
intraoperative fluid overload (IVF)
((injected fluid (ml) - diuresis (ml) - blood loss (ml))/weight before surgery)*100%
Measured: during the surgery
fluid overload (FO) on the first postoperative day in the ICU
((injected fluid (ml)-lost fluid (ml))/weight before admission to ICU)*100%
Measured: during the first postoperative day, exclude intraoperative period
total fluid overload on the first postoperative day
((injected fluid (ml) - lost fluid (ml))/weight before surgery)*100%
Measured: during the first postoperative day, include intraoperative period
Fraction of Inspired Oxygen (FiO2)
Fraction of Inspired Oxygen (FiO2)
Measured: in the the first postoperative day
Fraction of Inspired Oxygen (FiO2)
Fraction of Inspired Oxygen (FiO2)
Measured: in the second postoperative day
Fraction of Inspired Oxygen (FiO2)
Fraction of Inspired Oxygen (FiO2)
Measured: in the third postoperative day
Oxygen saturation (Sp02)
Oxygen saturation (Sp02)
Measured: in the first postoperative day
Oxygen saturation (Sp02)
Oxygen saturation (Sp02)
Measured: in the second postoperative day
Oxygen saturation (Sp02)
Oxygen saturation (Sp02)
Measured: in the third postoperative day
Venous oxygen saturation (Svo2)
Venous oxygen saturation (Svo2)
Measured: in the first postoperative day
Venous oxygen saturation (Svo2)
Venous oxygen saturation (Svo2)
Measured: in the second postoperative day
Venous oxygen saturation (Svo2)
Venous oxygen saturation (Svo2)
Measured: in the third postoperative day
partial pressure of carbon dioxide (pC02)
partial pressure of carbon dioxide (pC02)
Measured: in the first postoperative day
partial pressure of carbon dioxide (pC02)
partial pressure of carbon dioxide (pC02)
Measured: in the second postoperative day
partial pressure of carbon dioxide (pC02)
partial pressure of carbon dioxide (pC02)
Measured: in the third postoperative day
inspiratory pressure (Pin)
inspiratory pressure (Pin)
Measured: in the first postoperative day
inspiratory pressure (Pin)
inspiratory pressure (Pin)
Measured: in the second postoperative day
inspiratory pressure (Pin)
inspiratory pressure (Pin)
Measured: in the third postoperative day
Positive end-expiratory pressure (PEEP)
Positive end-expiratory pressure (PEEP)
Measured: in the first postoperative day
Positive end-expiratory pressure (PEEP)
Positive end-expiratory pressure (PEEP)
Measured: in the second postoperative day
Positive end-expiratory pressure (PEEP)
Positive end-expiratory pressure (PEEP)
Measured: in the third postoperative day
duration of ICU stay corrected to sedation
duration of ICU stay corrected for the duration of sedation
Measured: up to 30 days after the surgery
duration of MV corrected to sedation
duration of MV corrected for the duration of sedation
Measured: up to 30 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Dec 2020
- Primary completion20 Feb 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Water-Electrolyte ImbalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergey M Stepanenko, PhD, Prof., Study chair, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129930
- Sponsor's protocol ID
- FO-Coloesopfagoplasty
- Status last verified
- Dec 2020
- First submitted
- 7 Oct 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Overload and Pulmonary Function After Coloesophagoplasty in Children. Single-central Observational Study
- ClinicalTrials.gov ID
- NCT05129930
- Acronym / sponsor ID
- FO-Coloesopfagoplasty
- Conditions
- Water-Electrolyte Imbalance, Intensive Care Units, Pediatric, Critical Illness, Length of Stay, Respiratory Failure
- Keywords
- Liquid, Liquid overload, Mechanical ventilation, Infant, Preschool Child, Respiratory failure, Coloesophagoplasty, Esophageal atresia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 40 children with EA with/without TPF, aged from 1 month to 3 years, who underwent coloesophagoplasty at the N.F. Filatov Children city Hospital, Moscow, Russia, from December 1, 2017 to December 31, 2020.
Key inclusion criteria (4 listed)
- Аge from 1 month to 3 years
- EA with / without
- Tracheoesophageal fistula (TPF)
- Сoloesophagoplasty.
Key exclusion criteria (7 listed)
- Аesophageal burn,
- Oesophageal peptic stenosis,
- Congenital heart disease
- Cardiotonic support in the postoperative period
- Renal malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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)
intraoperative fluid overload (IVF)
Time frame: during the surgery
((injected fluid (ml) - diuresis (ml) - blood loss (ml))/weight before surgery)*100%
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%
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%
Fraction of Inspired Oxygen (FiO2)
Time frame: in the the first postoperative day
Fraction of Inspired Oxygen (FiO2)
Fraction of Inspired Oxygen (FiO2)
Time frame: in the second postoperative day
Fraction of Inspired Oxygen (FiO2)
Fraction of Inspired Oxygen (FiO2)
Time frame: in the third postoperative day
Fraction of Inspired Oxygen (FiO2)
Oxygen saturation (Sp02)
Time frame: in the first postoperative day
Oxygen saturation (Sp02)
Oxygen saturation (Sp02)
Time frame: in the second postoperative day
Oxygen saturation (Sp02)
Oxygen saturation (Sp02)
Time frame: in the third postoperative day
Oxygen saturation (Sp02)
Venous oxygen saturation (Svo2)
Time frame: in the first postoperative day
Venous oxygen saturation (Svo2)
Venous oxygen saturation (Svo2)
Time frame: in the second postoperative day
Venous oxygen saturation (Svo2)
Venous oxygen saturation (Svo2)
Time frame: in the third postoperative day
Venous oxygen saturation (Svo2)
partial pressure of carbon dioxide (pC02)
Time frame: in the first postoperative day
partial pressure of carbon dioxide (pC02)
partial pressure of carbon dioxide (pC02)
Time frame: in the second postoperative day
partial pressure of carbon dioxide (pC02)
partial pressure of carbon dioxide (pC02)
Time frame: in the third postoperative day
partial pressure of carbon dioxide (pC02)
inspiratory pressure (Pin)
Time frame: in the first postoperative day
inspiratory pressure (Pin)
inspiratory pressure (Pin)
Time frame: in the second postoperative day
inspiratory pressure (Pin)
inspiratory pressure (Pin)
Time frame: in the third postoperative day
inspiratory pressure (Pin)
Positive end-expiratory pressure (PEEP)
Time frame: in the first postoperative day
Positive end-expiratory pressure (PEEP)
Positive end-expiratory pressure (PEEP)
Time frame: in the second postoperative day
Positive end-expiratory pressure (PEEP)
Positive end-expiratory pressure (PEEP)
Time frame: in the third postoperative day
Positive end-expiratory pressure (PEEP)
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
duration of MV corrected to sedation
Time frame: up to 30 days after the surgery
duration of MV corrected for the duration of sedation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergey M Stepanenko, PhD, Prof. study chair
Pirogov Russian National Research Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Water-Electrolyte Imbalance and Intensive Care Units, run by Pirogov Russian National Research Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of intensive care unit (ICU) stay (time frame: up to 30 days after the surgery). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.