AscitesAscitesNCT03341221
Diagnosis of Ascites in Infants and Children
An observational study of Ascites, run by Assiut University.
Trial summary
Ascites is the pathologic accumulation of fluid within the peritoneal cavity. Causes of ascites in infants and children :hepatobiliary disorders,serositis, neoplasm, cardiac, genitourinary disorder, metabolic disease and others. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Ascites
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 1 Nov 2018
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Infants and children with ascites aged from 1month to 18 year
Who may be able to join
- age from 1month to 18 year
- infants and children with ascites (hepatic, cardiac, renal, malignant or tuberculous )
- infants and children with peritonitis
Who cannot join
- age <1month
- surgical conditions as ruptured viscous or located abscess
About this study
Ascites is the pathologic accumulation of fluid within the peritoneal cavity. Causes of ascites in infants and children :hepatobiliary disorders,serositis, neoplasm, cardiac, genitourinary disorder, metabolic disease and others.
Diagnosis of ascites :history of abdominal distention, increasing weight, respiratory embarrassement, symptoms and signs of (hepatic ,cardiac,renal disease, tuberculosis and malignancy).
lnvestigation:complete blood count, complete urine examination, liver function tests, plasma proteins, renal function tests, clotting screen, tuberculin test, chest and abdominal plain films,abdominal ultrasound, upper gastrointestinal endoscopy, abdominal paracentesis for ascitic fluid analysis .
Read the detailed description
Definition : Ascites is the pathologic fluid accumulation within the peritoneal cavity .
causes of ascites in infants and children :
- Hepatobiliary disorders (cirrhosis, congenital hepatic fibrosis, acute hepatitis B,C ,Budd -chiari syndrome, Bile duct perforation)
- Serositis (crohn's disease, eosinophilic enteropathy , Henoch- Shonlein purpura )
- Neoplasm (lymphoma, wilm's tumor ,Glioma, Germ cell tumor, Ovarian tumor,mesothelioma, Neroblastoma )
- Cardiac (Heart failure )
- Metabolic disease
- Gastrointestinal disorder (Nephrotic syndrome, peritoneal dialysis ). Diagnosis of ascites :History of abdominal distention, increasing weight, respiratory embarrassement, jaundice, bleeding (haematemsis, melena, and epistaxis ),Pruritus ,Growth failure ,abdominal pain, fever,Cyanosis, ,dyspnea during suckling, Orthopnea, Buffy eyes, lower limb swelling, Haematrruria .
By examination : Tachycardia ,Tachypnea ,Hypertension ,cyanosis, jaundice, clubbing of fingers ,limb edema ,Hepatomegaly, splenomegaly, dilated abdominal wall veins.
Investigations :
Laboratory tests :complete blood count , complete urine examination, liver function tests, plasma proteins, renal function tests, clotting screen, tuberculin test.
Imaging studies :chest and abdominal plain films, abdominal ultrasound, upper gastrointestinal endoscopy CT, MR I, Abdominal paracentesis for ascitic fluid analysis :cell count / cytology ,Gram 'stain and culture, Total proteins (albumin /globulin ratio ), Glucose, Amylase, lactase dehydrogenase, Triglycerides,Bilirubin.
Serum ascites albumin gradient (SAAG )is the best single test for classification of ascites into portal hypertensive (SAAG >1.1g/dl) and non-portal hypertensive (SAAG <1.1g/dl) causes.
- Conditions
- Ascites
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| One group | Diagnosis of ascites in infants and children by history, examination and investigations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of ascites in infants and children with hepatic, cardiac, renal disease, tuberculosis and malignancy
Diagnosis of ascites in infants and children fromega age of 1month to 18 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Nov 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AscitesStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa abo bakr Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341221
- Sponsor's protocol ID
- Assuit university 246810
- Acronym
- Ascites
- Status last verified
- Oct 2017
- First submitted
- 28 Oct 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Ascites in Infants and Children
- ClinicalTrials.gov ID
- NCT03341221
- Acronym / sponsor ID
- Ascites / Assuit university 246810
- Conditions
- Ascites
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 14 Nov 2017 (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.
Ascites is the pathologic accumulation of fluid within the peritoneal cavity. Causes of ascites in infants and children :hepatobiliary disorders,serositis, neoplasm, cardiac, genitourinary disorder, metabolic disease and others.
Diagnosis of ascites :history of abdominal distention, increasing weight, respiratory embarrassement, symptoms and signs of (hepatic ,cardiac,renal disease, tuberculosis and malignancy).
lnvestigation:complete blood count, complete urine examination, liver function tests, plasma proteins, renal function tests, clotting screen, tuberculin test, chest and abdominal plain films,abdominal ultrasound, upper gastrointestinal endoscopy, abdominal paracentesis for ascitic fluid analysis .
Detailed description
Definition : Ascites is the pathologic fluid accumulation within the peritoneal cavity .
causes of ascites in infants and children :
- Hepatobiliary disorders (cirrhosis, congenital hepatic fibrosis, acute hepatitis B,C ,Budd -chiari syndrome, Bile duct perforation)
- Serositis (crohn's disease, eosinophilic enteropathy , Henoch- Shonlein purpura )
- Neoplasm (lymphoma, wilm's tumor ,Glioma, Germ cell tumor, Ovarian tumor,mesothelioma, Neroblastoma )
- Cardiac (Heart failure )
- Metabolic disease
- Gastrointestinal disorder (Nephrotic syndrome, peritoneal dialysis ). Diagnosis of ascites :History of abdominal distention, increasing weight, respiratory embarrassement, jaundice, bleeding (haematemsis, melena, and epistaxis ),Pruritus ,Growth failure ,abdominal pain, fever,Cyanosis, ,dyspnea during suckling, Orthopnea, Buffy eyes, lower limb swelling, Haematrruria .
By examination : Tachycardia ,Tachypnea ,Hypertension ,cyanosis, jaundice, clubbing of fingers ,limb edema ,Hepatomegaly, splenomegaly, dilated abdominal wall veins.
Investigations :
Laboratory tests :complete blood count , complete urine examination, liver function tests, plasma proteins, renal function tests, clotting screen, tuberculin test.
Imaging studies :chest and abdominal plain films, abdominal ultrasound, upper gastrointestinal endoscopy CT, MR I, Abdominal paracentesis for ascitic fluid analysis :cell count / cytology ,Gram 'stain and culture, Total proteins (albumin /globulin ratio ), Glucose, Amylase, lactase dehydrogenase, Triglycerides,Bilirubin.
Serum ascites albumin gradient (SAAG )is the best single test for classification of ascites into portal hypertensive (SAAG >1.1g/dl) and non-portal hypertensive (SAAG <1.1g/dl) causes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group | – | –Diagnosis of ascites in infants and children by history, examination and investigations |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Infants and children with ascites aged from 1month to 18 year
Key inclusion criteria (3 listed)
- age from 1month to 18 year
- infants and children with ascites (hepatic, cardiac, renal, malignant or tuberculous )
- infants and children with peritonitis
Key exclusion criteria (2 listed)
- age <1month
- surgical conditions as ruptured viscous or located abscess
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
Diagnosis of ascites in infants and children with hepatic, cardiac, renal disease, tuberculosis and malignancy
Time frame: 1 year
Diagnosis of ascites in infants and children fromega age of 1month to 18 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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Development and Validation of a TIPS Prognostic Model
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ascites, 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 3 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: status not confirmed, as of the sponsor's last update on 14 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of ascites in infants and children with hepatic, cardiac, renal disease, tuberculosis and malignancy (time frame: 1 year). 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 14 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.