NCT03268460

Brief Summary

Providing summarized information on the clinical and biochemical characteristics and types of renal tubular acidosis in children in Assiut University Childern Hospital.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

August 28, 2017

Last Update Submit

August 30, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • percentage of cases with newly diagnosed renal tubular acidosis

    percentage of cases presented by metabolic acidosis , failure to thrive and polyuria and diagnosed as RTA by arterial blood gases, blood anion gap, serum electrolytes, kidney function tests and urine analysis.

    Baseline

Secondary Outcomes (1)

  • percentage of cases with each type of RTA

    Baseline

Interventions

Arterial blood gasesDIAGNOSTIC_TEST

blood PH, HCO3

Blood anion gapDIAGNOSTIC_TEST

(Na+) - (Cl- + HCO3-)

serum electrolytesDIAGNOSTIC_TEST

Na+ , K+ , Cl- and calcium

renal function testDIAGNOSTIC_TEST

blood urea and serum creatinine

urine analysisDIAGNOSTIC_TEST

urine PH, specific gravity, aminoaciduria, glycosuria, phospaturia and 24 hr urine calcium

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

• All cases presented with hypokalemia and normal anion gap hyperchloremic metabolic acidosis with a relatively normal glomerular filteration rate.

You may qualify if:

  • Age : From 1 year to 18 year.
  • Sex : Both sex male and female.
  • All cases presented with hypokalemia and normal anion gap hyperchloremic metabolic acidosis with a relatively normal glomerular filteration rate.

You may not qualify if:

  • Acute diarrhea .
  • Urinary diversions.
  • Post hypocapnia.
  • Postobstructive diuresis.
  • Interstitial nephritis.
  • Active urinary tract infection.
  • Intake of medications interfere with urinary acidification.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acidosis, Renal Tubular

Interventions

Blood Gas AnalysisAcid-Base EquilibriumKidney Function TestsUrinalysis

Condition Hierarchy (Ancestors)

Renal Tubular Transport, Inborn ErrorsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative TechniquesBiochemical PhenomenaChemical PhenomenaHydrogen-Ion ConcentrationMetabolismHomeostasisPhysiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaDiagnostic Techniques, Urological

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 31, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

September 1, 2017

Record last verified: 2017-08