Incidence of Renal Tubular Acidosis in Nephrology Unit in Assiut University Childern Hospital

August 30, 2017 updated by: Sally Ezzat Shafik mikhail, Assiut University

Incidence of Renal Tubular Acidosis in Nephrology Unit in Assiut University Childern Hospital (AUCH)

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

Study Overview

Detailed Description

The term renal tubular acidosis (RTA) is applied to a group of transport defects in the reabsorption of bicarbonate (HCO3_), the excretion of hydrogen ion (H_), or both. This condition was first described in 1935, confirmed as a renal tubular disorder in 1946, and designated "renal tubular acidosis" in 1951. The RTA syndromes are characterized by a relatively normal GFR and a metabolic acidosis accompanied by hyperchloremia and a normal plasma anion gap.

RTA is classified into 4 major forms: distal, proximal, hyperkalemic and combined RTA. Distal RTA is associated with reduced urinary acid secretion, proximal RTA ( pRTA ) is characterized by impaired bicarbonate (HCO3_) reabsorption, hyperkalemic RTA is an acid-base disturbance generated by aldosterone deficiency or resistance and combined RTA is due to carbonic anhydrase II deficiency. Electrolyte and acid-base disturbances are key components of each disorder .

Patients with pRTA present with growth failure in the 1st yr of life. Additional symptoms can include polyuria, dehydration (from sodium loss), anorexia, vomiting, constipation, and hypotonia. Patients with primary Fanconi syndrome have additional symptoms, secondary to phosphate wasting, such as rickets. Hypokalemia and related symptoms are also restricted to cases with the Fanconi syndrome.

Distal RTA shares features with those of pRTA, including non-anion gap metabolic acidosis and growth failure; distinguishing features of distal RTA include nephrocalcinosis and hypercalciuria Combined proximal and distal RTA is a type observed as the result of inherited carbonic anhydrase II deficiency in different organs and systems.

Patients with type IV RTA can present with growth failure in the first few years of life. Polyuria and dehydration (from salt wasting) are common. Laboratory tests reveal a hyperkalemic non-anion gap metabolic acidosis. Urine may be alkaline or acidic. Elevated urinary sodium levels with inappropriately low urinary potassium levels reflect the absence of aldosterone effect .

The first step in the evaluation of a patient with suspected RTA is to confirm the presence of a normal anion gap metabolic acidosis, identify electrolyte abnormalities, assess renal function, and rule out other causes of bicarbonate loss such as diarrhea .

The mainstay of therapy in all forms of RTA is bicarbonate replacement. Patients with pRTA often require large quantities of bicarbonate, up to 20 mEq/kg/24 hr. The base requirement for distal RTAs is generally in the range of 2-4 mEq/kg/24 hr, although patients' requirements can vary. Patients with type IV RTA can require chronic treatment for hyperkalemia with sodium potassium exchange resin .

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of cases with newly diagnosed renal tubular acidosis
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of cases with each type of RTA
Time Frame: Baseline
this is by measurement of serum K+ and urine PH. normal or low level of serum K+ with urine PH < 5,5 with proximal RTA, while normal or low level of serum K+ with urine PH > 5,5 with distal RTA. high level of serum K+ with urine PH < 5,5 with hyperkalemic type 4 RTA, while high level of serum K+ with urine PH > 5,5 with voltage defect distal RTA
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

August 28, 2017

First Submitted That Met QC Criteria

August 29, 2017

First Posted (Actual)

August 31, 2017

Study Record Updates

Last Update Posted (Actual)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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