ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 6 for:    "Renal tubular acidosis"
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03268460
Recruitment Status : Not yet recruiting
First Posted : August 31, 2017
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Sally Ezzat Shafik mikhail, Assiut University

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

Condition or disease Intervention/treatment
Renal Tubule Acidosis Diagnostic Test: Arterial blood gases Diagnostic Test: Blood anion gap Diagnostic Test: serum electrolytes Diagnostic Test: renal function test Diagnostic Test: urine analysis

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
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Incidence of Renal Tubular Acidosis in Nephrology Unit in Assiut University Childern Hospital (AUCH)
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019



Intervention Details:
  • Diagnostic Test: Arterial blood gases
    blood PH, HCO3
  • Diagnostic Test: Blood anion gap
    (Na+) - (Cl- + HCO3-)
  • Diagnostic Test: serum electrolytes
    Na+ , K+ , Cl- and calcium
  • Diagnostic Test: renal function test
    blood urea and serum creatinine
  • Diagnostic Test: urine analysis
    urine PH, specific gravity, aminoaciduria, glycosuria, phospaturia and 24 hr urine calcium


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268460


Contacts
Contact: Sally Ezzat 01001349860 ext 00+20 sallyezzat1992@gmail.com

Sponsors and Collaborators
Assiut University

Responsible Party: Sally Ezzat Shafik mikhail, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03268460     History of Changes
Other Study ID Numbers: RTA in childern
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Acidosis
Acidosis, Renal Tubular
Acid-Base Imbalance
Metabolic Diseases
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn