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.
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
- Conditions the study is for
- Gastrointestinal Manifestations in Critically Ill Children
- 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.
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
- 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.
- 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.
- 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.
- 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.
- 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.
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.
- First posted1 Feb 2024
- Study start1 Sep 2024 (estimated)
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Manifestations in Critically Ill ChildrenStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Abdalla Hashem Ahmed, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross Sectional Prospective Study on Critically Ill Children Admitted in PICU of Children's Hospital Assuit University
- ClinicalTrials.gov ID
- NCT06235528
- Acronym / sponsor ID
- GIT manifestations
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 1 Feb 2024 (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.
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
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
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children admitted to PICU who have GIT manifestations after admission as sequel of other diseases
Key inclusion criteria (1 listed)
- 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…)
Key exclusion criteria (2 listed)
- Age more than 18 years old
- Children have no GIT Complications
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
describe demographic and clinical data of critically ill children with Gastrointestinal manifestations admitted to PIUC
Time frame: 2 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
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.
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.