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Not yet recruitingNCT06235528Updated Apr 22, 2024

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

An observational study in Gastrointestinal Manifestations in Critically Ill Children, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2024-04-22.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
83
Ages
1 Month to 18 Years
Sex
All
01

Study 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). 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.
02

Conditions studied

  • Gastrointestinal Manifestations in Critically Ill Children

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03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's planned enrollment of 83 is below the median of 130 across 867 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • 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...)

Exclusion criteria

Exclusion Criteria:

  • Age more than 18 years old
  • Children have no GIT Complications
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
83 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  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

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06235528
Lead sponsor
Assiut University
Responsible party
Marwa Abdalla Hashem Ahmed (71515, Assuit University, Assiut University) — Principal investigator
First posted
Feb 1, 2024
Start date
Sep 1, 2024 (estimated)
Primary completion
Sep 25, 2026 (estimated)
Completion
Nov 25, 2026 (estimated)
Last update
Apr 22, 2024

Study contacts

marwa abdalla hashem ahmed
Contact
rhmaabdalla@icloud.com
01095101462
Ismail Lotfy Mohamad, professior
Contact
Ismail231@aunedu.eg
01063398967

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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