Prevalence of Acute Kidney Injury in Patients With Diabetic Ketoacidosis

prevalence of acute kidney injury in patients with diabetic ketoacidosis

Study Overview

• Status: Not yet recruiting
• Conditions: AKI in Diabetic Ketoacidosis
• Intervention / Treatment: Diagnostic test: renal chemistry, serum electrolyte,

Detailed Description

Acute kidney injury (formerly known as acute renal failure) is a syndrome characterised by the rapid loss of the kidney's excretory function and is typically diagnosed by the accumulation of end products of nitrogen metabolism (urea and creatinine) or decreased urine output, or both.

• Stages of kidney injury:

  1. Risk: 1.5 folds increase in serum creatinine and urine output less than 0.5 ml/kg/hr for 6 hours.
  2. Injury: two folds increase in serum creatinine and urine output less than 0.5 ml/kg/hr for 12 hours.
  3. Failure: three folds increase in serum creatinine and urine output less than 0.3 ml/kg/hr for 24 hours or anuria for 12 hours.
  4. Loss: complete loss of kidney function > 4 weeks

  5. End stage kidney disease: complete loss of kidney function > 3 months It is the clinical manifestation of several disorders that affect the kidney acutely. Acute kidney injury is common in hospital patients and very common in critically ill patients. In these patients, it is most often secondary to extrarenal events. How such events cause acute kidney injury is controversial. No specific therapies have emerged that can attenuate acute kidney injury or expedite recovery; thus, treatment is supportive. New diagnostic techniques (eg, renal biomarkers) might help with early diagnosis. Patients are given renal replacement therapy if acute kidney injury is severe and biochemical or volume-related, or if uraemic-toxaemia-related complications are of concern. If patients survive their illness and do not have premorbid chronic kidney disease, they typically recover to dialysis independence. However, evidence suggests that patients who have had acute kidney injury are at increased risk of subsequent chronic kidney disease.

     Children with diabetic ketoacidosis (DKA) are at significant risk for various degrees of dehydration and disruption of electrolyte balance due to osmotic diuresis [1]. As a consequence of chronic polyuria, progressive dehydration is common in patients with DKA [2]. Children are less likely to establish the compensatory process for dehydration than adults, making them more vulnerable to dehydration [3]. In patients with extreme volume loss, pre-renal acute kidney injury (AKI) is likely, and acute tubular necrosis can occur. As the rate of glomerular filtration decreases, there is insufficient kidney acid excretion, thereby aggravating metabolic acidosis [4]. Since metabolic acidosis normalization is one of the goals of DKA management [1], AKI can adversely affect recovery from metabolic acidosis for these patients. Besides, AKI is an independent risk factor for a prolonged hospital stay and increased mortality rates [5]. DKA is managed by volume resuscitation, insulin therapy, and correction of electrolyte imbalances [6]. Resuscitation using traditional saline in DKA patients can exacerbate electrolyte abnormalities, in particular the production of hyperchloremia [7, 8]. While an increase of evidence suggests that hyperchloremia is linked to an increased risk of morbidity and mortality, its effects in DKA are not well defined [9, 10].

     Aim of study 1: to detect prevalence of acute kidney injury in pediatric patients with diabetic ketoacidosis and its impact as regard to;

• duration of hospital stay.
• Occurance of complications
• response to treatment. 2: to detect the type of kidney injury in diabetic ketoacidosis wether it is renal or pre renl.

Type of study Observational Cross-Sectional study

Sample size Sample size will be determined through statistical analysis by Public health department

Patients and methods All included children were subjected to

1. detailed medical history including demographic data (name, age, and sex), age of onset, family history of type 1 diabetes mellitus (DM1), and duration of the disease, previous attacks of DKA.
2. clinical examination with particular emphasis on assessment of anthropometric measures (weight and height), evaluation of systolic and diastolic blood pressures, monitoring of urine output (UOP), and recording of complications (cerebral edema, sepsis, need for vasoactive drugs, need for respiratory support and mortality).
3. laboratory investigations including daily urine output, urea, creatinine, serum chloride level, Na, K and arterial blood gases (ABG) every third day and albumin/creatinine ratio (ACR) every week.

Follow-up of blood urea and creatinine till normalization of kidney function or occurance of failure.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Ahmed Refaat, resident doctor; Phone Number: 01012581156; Email: ahmedrefaat1995227@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All included children were subjected to

1. detailed medical history including demographic data (name, age, and sex), age of onset, family history of type 1 diabetes mellitus (DM1), and duration of the disease, previous attacks of DKA.
2. clinical examination with particular emphasis on assessment of anthropometric measures (weight and height), evaluation of systolic and diastolic blood pressures, monitoring of urine output (UOP), and recording of complications (cerebral edema, sepsis, need for vasoactive drugs, need for respiratory support and mortality).
3. laboratory investigations including daily urine output, urea, creatinine, serum chloride level, Na, K and arterial blood gases (ABG) every third day and albumin/creatinine ratio (ACR) every week.

Follow-up of blood urea and creatinine till normalization of kidney function or occurance of failure.

Description

Inclusion Criteria:

• The inclusion criterion was children with DKA with an age range between 1 and 18 years

Exclusion Criteria:

• The exclusion criteria were patients with septic shock, acute pancreatitis, and chronic kidney disease and patients who received fluid therapy before referral to our hospital

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of acute kidney injury in diabetic ketoacidosis	detection of renal function affection and electrolyte disturbance in patients with diabetic ketoacidosis	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Yang EM, Lee HG, Oh KY, Kim CJ. Acute Kidney Injury in Pediatric Diabetic Ketoacidosis. Indian J Pediatr. 2021 Jun;88(6):568-573. doi: 10.1007/s12098-020-03549-9. Epub 2020 Nov 19.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2023
• Primary Completion (ANTICIPATED): April 30, 2024
• Study Completion (ANTICIPATED): April 30, 2024

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (ACTUAL): August 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Renal Insufficiency; Acid-Base Imbalance; Acute Kidney Injury; Acidosis; Ketosis; Diabetic Ketoacidosis
• Other Study ID Numbers: AKI in DKA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No