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Gastrointestinal Manifestations in Critically Ill ChildrenNCT06235528

Gastrointestinal Manifestations in Critically Ill Children Admitted in PICU of Children's Hospital Assuit University

An observational study of Gastrointestinal Manifestations in Critically Ill Children, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Gastrointestinal complications are common in critically ill children. GIC are commonly observed, as either a primary reason for admission or as a part of multiple organ dysfunction syndromes MODS in children admitted in the Pediatric Intensive Care Unit (PICU). Read more about this study

Who is it for?
Ages 1 month to 18 years
How many people
83 participants
Where
No sites listed yet
Study dates
1 Sep 2024to 25 Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years
  • All sexes
  • Child, Adult

Study population: Children admitted to PICU who have GIT manifestations after admission as sequel of other diseases

Who may be able to join

  • All children admitted to PICU with age one month to 18 years of both gender and have developed GIT manifestations after admission as a sequel of other diseases (intestinal perforation, intestinal obstruction, necrotizing fasciitis…)

Who cannot join

  • Age more than 18 years old
  • Children have no GIT Complications

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

marwa abdalla hashem ahmed contact

01095101462

rhmaabdalla@icloud.com

Ismail Lotfy Mohamad, professior contact

01063398967

Ismail231@aunedu.eg

About this study

Official title: A Cross Sectional Prospective Study on Critically Ill Children Admitted in PICU of Children's Hospital Assuit University

Gastrointestinal complications are common in critically ill children. GIC are commonly observed, as either a primary reason for admission or as a part of multiple organ dysfunction syndromes MODS in children admitted in the Pediatric Intensive Care Unit (PICU). Despite its prominence in critically ill patients with MODS.

GIC are often ignored in PICU which often delays enteral nutrition preventing patients from getting adequate calorie and protein intake, ultimately leading to acquired malnutrition in these patients. The lack of a uniform standard definition of GIC adds to delays in its recognition. Critical illness can result in intestinal mucosal ischemia that further damages the gut barrier function

Read the detailed description

Gastrointestinal complications are common in critically ill children. GIC are commonly observed, as either a primary reason for admission or as a part of multiple organ dysfunction syndromes in children admitted in the Pediatric Intensive Care Unit . Despite its prominence in critically ill patients with MODS.

GIC are often ignored in PICU which often delays enteral nutrition preventing patients from getting adequate calorie and protein intake, ultimately leading to acquired malnutrition in these patients. The lack of a uniform standard definition of GIC adds to delays in its recognition. Critical illness can result in intestinal mucosal ischemia that further damages the gut barrier function.

Recently with the increasing awareness of GIC in critically ill patients, the Working Group on Abdominal Problems of the European Society of Intensive Care Medicine proposed a set of definitions of acute gastrointestinal injury in critical illnesses in adults for both clinical and research purposes. However, there is no such definition available for the pediatric population. Also, the associations between AGI grades, the severity of GI dysfunction and adverse outcome remains to be elucidated.

Reintam et al reported an incidence of GIC of 59% in their mixed-ICU population. Common GIC included vomiting, high gastric residual volume , bowel distension, diarrhea, and GI bleeding, in their report. There is limited published literature on the frequency and outcome of GIC related to enteral feeding in critically ill children. Critically ill patients with GIC have a prolonged length of stay in ICU and higher mortality as compared to those without Gastrointestinal complications The most common symptoms of GIT issues, regardless of cause, are vomiting and diarrhea. Gastroenteritis resulting from an infection can also cause fever. Abdominal pain is also common.

Most encountered gastrointestinal problems in critically ill children will be discussed:

•Dehydration, Gastrointestinal bleeding, Dysmotility, Constipation, Malnutrition

  1. Dehydration: The most common cause of dehydration in young children is severe diarrhea and vomiting. Older adults naturally have a lower volume of water in their bodies, and may have conditions or take medications that increase the risk of dehydration. , seriously dehydrated children become listless, irritable, or sluggish . Infants are much more likely than older children to become dehydrated and develop serious side effects. Infants who are dehydrated need medical care right away.
  2. Gastrointestinal Bleeding: GI bleeding is associated with risk factors such as respiratory failure, coagulopathy, or PRISM score >10. Pathophysiology is complex and begins with vasoconstriction and ischemia, eventually leading to bleeding that results from stress ulcerations, called stress ulcer-related bleeding . Upper GI bleeding has different pathophysiological mechanisms, for example, in acid reflux-related esophagitis. It has also been documented that acid suppression does not prevent UGIB or SURB. Stress ulcers are caused by decreased mucosal blood flow and reperfusion injury and less related to chronic acid secretion-related peptic ulcers. Exact pathophysiology is not fully understood.
  3. Dysmotility In the critically ill child causes delayed gastric emptying (GE) or gastroparesis. It has been reported in up to 50% of critically ill children. Potential for aspiration, ventilator-associated pneumonia, inadequate enteral nutrition, and resulting poor efficacy of enteral medications results in poor patient outcomes. Gastric dysmotility in a critically ill child may accompany gastroesophageal reflux , with high risk for aspiration and ventilator-associated pneumonia in mechanically ventilated patients.
  4. Constipation Constipation in a critically ill child is a poorly studied disease which can represent up to 50% of children admitted to Pediatric Intensive Care Units. In one pediatric study, it was found to be common in postsurgical, older, and obese children and ones with fecal continence p value < 0.01. Patients with constipation had higher severity PIM2: Pediatric Index of Mortality 2 scores and started nutrition later and with a lower volume p value < 0.01. Overall management included enemas and/or oral laxatives. Major independent risk factors are body weight, PIM2 clinical severity score, ICU admission after surgery, and the need for vasoconstrictor therapy, resulting in intestinal hyperpermeability as well as associated therapies such as vasoconstrictor therapy, and overall management mainly remains empirical.
  5. Malnutrition In the ill child, malnutrition is usually of multifactorial origin. It is associated with an altered metabolism of certain substrates, increased or decreased metabolism and catabolism depending on the severity and kind of the lesion, and reduced nutrient delivery. The presence of malnutrition prior to admission worsens the prognosis in the critically ill child and, furthermore, severe illness has marked repercussions on the nutritional status of these patients Malnutrition interferes with the appropriate response of the body to disease and predisposes to infection and to the onset of multiorgan failure, increasing morbidity and mortality, the mean length of hospital stay, and health costs.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. describe demographic and clinical data of critically ill children with Gastrointestinal manifestations admitted to PIUC

    Describe the distribution of etiologies of Gastrointestinal manifestations admitted to PIUC,The most common symptoms of GIT issues, regardless of cause, are vomiting and diarrhea. Gastroenteritis resulting from an infection can also cause fever. Abdominal pain is also common

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion25 Sep 2026 (estimated)
  4. Study completion25 Nov 2026 (estimated)

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
83 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06235528
Sponsor's protocol ID
GIT manifestations
Status last verified
Apr 2024
First submitted
9 Dec 2023
Last updated
22 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Gastrointestinal Manifestations in Critically Ill Children, run by Assiut University.

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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact marwa abdalla hashem ahmed (01095101462, rhmaabdalla@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

describe demographic and clinical data of critically ill children with Gastrointestinal manifestations admitted to PIUC (time frame: 2 years). 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 Apr 2024.

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