IVC Index in Patient With Diarrhea and Dehydration And How It Affects Its Management

• ClinicalTrials.gov Identifier: NCT04654832
• Recruitment Status: Recruiting
• First Posted: December 4, 2020
• Last Update Posted: December 4, 2020
• Sponsor: Assiut University
• Information provided by (Responsible Party): Reham Refaat abd elhafez, Assiut University

Study Description

Brief Summary:

IVC Index in patient with Diarrhea and Dehydration And How It affects its management.

Condition or disease
Diarrhea, Infantile

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

• Study Type: Observational
• Estimated Enrollment: 57 participants
• Observational Model: Case-Crossover
• Time Perspective: Cross-Sectional
• Official Title: IVC Index in Patient With Diarrhea and Dehydration And How It Affects Its Management
• Actual Study Start Date: October 1, 2020
• Estimated Primary Completion Date: December 29, 2020
• Estimated Study Completion Date: December 29, 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. (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

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 5 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

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)

Criteria

(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.

Contacts and Locations

Contacts

Contact: Reham RR Refaat, Master; 01094494643; ryhamrema@yahoo.com

Locations

Egypt

Reham; Recruiting

Assiut, Egypt

Contact: Elsayed Khalil, Professor 0106 080 5170

Contact: Duaa Mohammad, Professor 0122 311 2124 Diana.ahmed3@med.au.edu.eg

Sponsors and Collaborators

Assiut University

Investigators

• Study Director: Elsayed Khalil Abd elkarem, Professor; Assiut University
• Study Director: Duaa Mohamad raafat, Assistant; Assiut University

More Information

• Responsible Party: Reham Refaat abd elhafez, Assistant lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT04654832
• Other Study ID Numbers: IVC Index
• First Posted: December 4, 2020
• Last Update Posted: December 4, 2020
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Reham Refaat abd elhafez, Assiut University:

IVC Index

Additional relevant MeSH terms:

Dehydration; Diarrhea; Diarrhea, Infantile; Signs and Symptoms, Digestive; Water-Electrolyte Imbalance; Metabolic Diseases; Pathologic Processes