Diarrhea, InfantileNCT04654832
IVC Index in Patient With Diarrhea and Dehydration And How It Affects Its Management
An observational study of Diarrhea, Infantile, run by Assiut University at 1 site in Egypt.
Trial summary
IVC Index in patient with Diarrhea and Dehydration And How It affects its management. Read more about this study
- Who is it for?
- Ages 1 month to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Infantile
- How many people
- 57 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 29 Dec 2020
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: *Sample size: According to the G*Power 3 software (Faul et al., 2007); the calculated minimum sample was 57 patient with dehydration needed to detect an effect size of 0.5 in the percentage of weight change after rehydration (12), with an error probability of 0.05 and 95 % power on a two-tailed test, it expected to be done from 1 October2020 till 29 December2021.(13)
(Inclusion Criteria):
- Patients under 5years old who Presented with acute diarrhea and clinical evidence of significant (Moderate and severe) dehydration and sepsis based on blood picture ,high grade fever and CRP
- Patients under 5 years old with dehydration and non septic condition.
- Patients under 5years old have cardiomyopathy previously diagnosed. (Exclusion Criteria ):
- Patients receiving oral rehydration solution only .
- chronic medical conditions, bronchopulmonary dysplasia and renal and liver diseases.
- Children with acute blood loss were also excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Reham
Asyut
Elsayed Khalil, Professor, 0106 080 5170
Duaa Mohammad, Professor, 0122 311 2124, Diana.ahmed3@med.au.edu.eg
About this study
IVC Index in patient with Diarrhea and Dehydration And How It affects its management.
Read the detailed description
Introduction The world health organization defines dehydration as condition that result from excessive loss of body water .the most common cause of dehydration in children are vomiting and diarrhea. Dehydration is a major cause of morbidity and mortality in infant and young children world wide .most cases due to consequence of acute gastroenteritis.
Pathophysiology. Dehydration cause decrease in total body water in both intracellular and extracellular fluid volume. Volume depletion closely correlate with sign and symptom of dehydration .the total body water is higher in infant and children compared to adult.
In infant, it is 70% of total body weight, whereas it is 65%and 60% respectively in children and adult.
The World Health Organization recommends assessing dehydration in children based on four clinical features: general appearance , eyes (whether they appear sunken), history of thirst , and skin pinch to assess turgor. However, these clinical signs may be subtle or non specific and thus have important limitations if used as independent predictors of dehydration. A more objective way to assess for dehydration using urine analysis has been implicated.
Additionally, studies on dehydration have shown urine analysis do not show sufficient sensitivity, Specificity or reliability [3, 4] and are typically only useful in children with moderate to severe hypovolemia.
. Bedside ultrasonography is a noninvasive method that can serve as a more objective tool for assessing dehydration in both adults and children. Point-of-care ultrasound has the potential to reduce unnecessary use of resources such as IV fluids or hospital access, while identifying children who are severely dehydrated and need immediate medical attention. Previous studies have shown that intravascular volume correlates to the diameters of the inferior vena cava.
- The normal IVC diameter is 15_ 17mm
- small IVC (usually < 12mm) with spontaneous collapse is often seen in the presence of intravascular volume depletion.
Bedside emergency ultrasonography (EUS) is a relatively new imaging modality in pediatrics.(8,9) EUS is fast, painless, and noninvasive. In recent years, many new pediatric indications for EUS have been developed.
Ultrasonography (US) assessment of the inferior vena cava (IVC) has been used as a noninvasive diagnostic tool for the assessment of intravascular volume and right heart function. Specifically, IVC diameter and collapsibility have been used as methods of assessing fluid status in dehydrated patients .
In these studies, contraction of the intravascular volume resulted in measurable decreases in IVC diameters. Conversely, research has shown that the diameter of the descending aorta (Ao) remains mostly constant, despite intravascular volume depletion.
- Conditions
- Diarrhea, Infantile
- Keywords
- IVC Index
- Medical subject headings
- Diarrhea, Infantile
What is being measured
The primary outcome is the main question the study is designed to answer.
(IVC Index in patient with Diarrhea and Dehydration and how it affects it's management.)
Assessment of dehydration by ivc index and bcmanagement according to this index
Measured: IVC Index in patient with Diarrhea and Dehydration And How It affects its management21.(13). it expect it expected to be done from 1 October2020 till 29 December2021.(13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Oct 2020
- Primary completion29 Dec 2020 (estimated)
- Study completion29 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea, InfantileStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Refaat abd elhafez, Assiut University
- Investigators
- Elsayed Khalil Abd elkarem, Professor, Study director, Assiut UniversityDuaa Mohamad raafat, Assistant, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654832
- Sponsor's protocol ID
- IVC Index
- Status last verified
- Dec 2020
- First submitted
- 19 Oct 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVC Index in Patient With Diarrhea and Dehydration And How It Affects Its Management
- ClinicalTrials.gov ID
- NCT04654832
- Acronym / sponsor ID
- IVC Index
- Conditions
- Diarrhea, Infantile
- Keywords
- IVC Index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 29 Dec 2020 (estimated)
- Study completion
- 29 Dec 2020 (estimated)
- First posted
- 4 Dec 2020 (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.
IVC Index in patient with Diarrhea and Dehydration And How It affects its management.
Detailed description
Introduction The world health organization defines dehydration as condition that result from excessive loss of body water .the most common cause of dehydration in children are vomiting and diarrhea. Dehydration is a major cause of morbidity and mortality in infant and young children world wide .most cases due to consequence of acute gastroenteritis.
Pathophysiology. Dehydration cause decrease in total body water in both intracellular and extracellular fluid volume. Volume depletion closely correlate with sign and symptom of dehydration .the total body water is higher in infant and children compared to adult.
In infant, it is 70% of total body weight, whereas it is 65%and 60% respectively in children and adult.
The World Health Organization recommends assessing dehydration in children based on four clinical features: general appearance , eyes (whether they appear sunken), history of thirst , and skin pinch to assess turgor. However, these clinical signs may be subtle or non specific and thus have important limitations if used as independent predictors of dehydration. A more objective way to assess for dehydration using urine analysis has been implicated.
Additionally, studies on dehydration have shown urine analysis do not show sufficient sensitivity, Specificity or reliability [3, 4] and are typically only useful in children with moderate to severe hypovolemia.
. Bedside ultrasonography is a noninvasive method that can serve as a more objective tool for assessing dehydration in both adults and children. Point-of-care ultrasound has the potential to reduce unnecessary use of resources such as IV fluids or hospital access, while identifying children who are severely dehydrated and need immediate medical attention. Previous studies have shown that intravascular volume correlates to the diameters of the inferior vena cava.
- The normal IVC diameter is 15_ 17mm
- small IVC (usually < 12mm) with spontaneous collapse is often seen in the presence of intravascular volume depletion.
Bedside emergency ultrasonography (EUS) is a relatively new imaging modality in pediatrics.(8,9) EUS is fast, painless, and noninvasive. In recent years, many new pediatric indications for EUS have been developed.
Ultrasonography (US) assessment of the inferior vena cava (IVC) has been used as a noninvasive diagnostic tool for the assessment of intravascular volume and right heart function. Specifically, IVC diameter and collapsibility have been used as methods of assessing fluid status in dehydrated patients .
In these studies, contraction of the intravascular volume resulted in measurable decreases in IVC diameters. Conversely, research has shown that the diameter of the descending aorta (Ao) remains mostly constant, despite intravascular volume depletion.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- *Sample size: According to the G*Power 3 software (Faul et al., 2007); the calculated minimum sample was 57 patient with dehydration needed to detect an effect size of 0.5 in the percentage of weight change after rehydration (12), with an error probability of 0.05 and 95 % power on a two-tailed test, it expected to be done from 1 October2020 till 29 December2021.(13)
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
(IVC Index in patient with Diarrhea and Dehydration and how it affects it's management.)
Time frame: IVC Index in patient with Diarrhea and Dehydration And How It affects its management21.(13). it expect it expected to be done from 1 October2020 till 29 December2021.(13)
Assessment of dehydration by ivc index and bcmanagement according to this index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
Related trials for Diarrhea, Infantile
Recruiting
Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete
Infantile Colics, Constipation
Recruiting
Whole Genome Sequencing Versus Whole Exome Sequencing for Congenital Diarrhea and Enteropahty
Diarrhea, Infantile, Enteropathy
RecruitingPhase 1/2
Fortified Oral Rehydration Therapy for Pediatric Diarrhea
Acute Gastroenteritis
Recruiting
BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months
Infantile Colic, Gastroesophageal Reflux (GER)
RecruitingObservational study
Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China
Diarrhea Infantile
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.
Elsayed Khalil Abd elkarem, Professor study director
Assiut University
Duaa Mohamad raafat, Assistant study director
Assiut 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 Diarrhea, Infantile, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 4 Dec 2020. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reham RR Refaat, Master (01094494643, ryhamrema@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(IVC Index in patient with Diarrhea and Dehydration and how it affects it's management.) (time frame: IVC Index in patient with Diarrhea and Dehydration And How It affects its management21.(13). it expect it expected to be done from 1 October2020 till 29 December2021.(13)). 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 4 Dec 2020.