- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05598866
Correlation Between Serum Chloride and Anion Gap Levels in DKA Patients
Correlation Between the Serum Chloride Levels and the Anion Gap Values in the Initial Fluid Resuscitation in DKA Patients and Its Relation to Outcome
2.2 Aim(s) of the Research (50 words max):
- To examine the description and correlation of changes in the serum chloride levels and changes in the anion gap values before and after fluid resuscitation in patients with DKA and to examine the description and correlation of changes in the serum chloride.
- relation of serum chloride and outcome in patients with DKA
Study Overview
Status
Detailed Description
Diabetic ketoacidosis (DKA) is one of the most serious and acute complications of diabetes. DKA is a significant contributor to mortality, costs, and poor quality of life.
The total incidence of DKA tends to increase, mainly due to an increase in type 2 diabetes cases and obesity.
DKA consists of the biochemical triad of hyperglycemia, ketonemia, and metabolic acidosis resulting from absolute or relative insulin deficiency and an increase in counter-regulatory hormones. These life-threatening consequences produce severe body water deficit, the accumulation of ketone bodies, and electrolyte disturbances.
Hyperglycemia develops because of three processes: increased gluconeogenesis, accelerated glycogenolysis, and impaired glucose utilization by peripheral tissues. The hyperglycemia will lead to glycosuria and osmotic diuresis, resulting in hyperosmolar intracellular dehydration.
In DKA, fluid deficits may be up to 10% of total body weight and electrolyte deficits in the body, one of which is chloride.
In DKA, lipolysis resulting in high circulating levels of free fatty acids may occur. These free fatty acids are taken up by the liver and oxidized to ketone bodies. Excessive production of ketone bodies in the anionic form can cause high plasma anion gap. Ketone bodies are relatively strong acids that dissociate at physiologic pH. The dissociation in the form of H+ ions will be buffered by bicarbonate. When the plasma bicarbonate concentrations decrease, a high anion gap acidosis metabolic (HAGMA) develops. The anion gap calculation formula is [Na+ (Cl-+ HCO3)]. Based on diagnostic criteria, the anion gap value in DKA >10. The increased anion gap is a predictor of metabolic acidosis, and the degree of metabolic acidosis can be estimated by the size of the anion gap. Initial management of adult patients with DKA is rehydration with normal saline fluid (0.9% NaCl) intravenously and insulin administration (when the serum potassium levels <3.3 mEq/L). The initial dose of normal saline infusion is 15-20 mL/kg/hour over the first hour.
Subsequent amount of fluid given depends on the hydration status, hemodynamic conditions, and electrolyte levels. Electrolyte levels are monitored after 2 hours of initial fluid resuscitation.
The goals of rapid rehydration are to improve the circulatory volume and tissue perfusion, clear ketone bodies, and correct electrolyte imbalances. Normal saline contains 154 mEq/L chloride and 154 mEq/L sodium.
The chloride concentration of saline is higher than that of human plasma (97-107 mEq/L).
Normal saline (0.9% sodium chloride) is a low-cost and easy-to-find crystalloid fluid which becomes fluid choice by doctors in some cases. However, normal saline is now under observation due to concerns about hyperchloremic metabolic acidosis, oliguria, prolonged acidosis, and coagulopathy. Consistent data are found regarding increased serum chloride levels associated with complications of acidosis, AKI, or electrolyte disturbances after being given at least 2 liters of normal saline. An increase in the chloride levels is not counterbalanced by an increase in the bicarbonate ion concentrations in plasma. Although the anion gap values decrease, acidosis still occurs. Thus, normal anion gap metabolic acidosis (NAGMA) or hyperchloremic acidosis arises.
Blood glucose level <200 mg/dL, serum bicarbonate level >15 mEq/L, pH >7.3, and normal anion gap are recovery signs of DKA.12 causes of hyperchloremia include: Gastrointestinal problems, such as vomiting or diarrhea. heat exposure, Diabetes insipidus, Some medications, particularly hormones as estrogens, diuretics, corticosteroids,and certain,chemotherapy Starvation due to eating disorders, severe malnourishment, or problems absorbing nutrients from food.
Addison's disease, diabetes insipidus,burns, kidney disease, kidney failure, and renal tubular acidosis
Hypochloremia can be caused by:
Diarrhea Vomiting Excessive sweating Kidney problems Chronic respiratory acidosis, Syndrome of inappropriate antidiuretic hormone excretion (SIADH), Metabolic alkalosis, Use of certain medications like corticosteroids, diuretics, laxatives, and bicarbonates
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mervat Mokhles Fathy
- Phone Number: 01002488659
- Email: Mokhlesmervat@gmail.com
Study Contact Backup
- Name: Mokhles Fathy Sayed
- Phone Number: 01007846510
Study Locations
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Assiut, Egypt
- Assiut university hospitals
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Contact:
- Assiut Hospitals, Master
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
any patients admitted to intensive care unit, critical care unit in Assuit university from……to……..
- Blood glucose level >250 mg/dl ( normal 70-100)
- Ph<7.3 ( normal PH 7.35- 7.45)
- Hco3<15 m mol/litre ( normal HCO3 22-26)
- Serum chloride before resucitation <107m mol/litre (normal 96- 106)
- Urea <6.5 m mol/litre
- S.create <120 m mol/litre
Description
Inclusion Criteria:
- any patients admitted to intensive care unit, critical care unit in Assuit university from 15 yrs to 70
- Blood glucose level >250 mg/dl ( normal 70-100)
- Ph<7.3 ( normal PH 7.35- 7.45)Hco3<15 m mol/litre ( normal HCO3 22-26)
- Serum chloride before resucitation <107m mol/litre (normal 96- 106)
- Urea <6.5 m mol/litre
- S.create <120 m mol/litre
Exclusion Criteria:
- Patients receiving chemotherapy, diuretics, corticosteroids, laxatives
- Patients diagnosed to have Addison disease
- Patients with chronic kidney disease and acute kidney injury, end stage renal disease, renal tubular acidosis
- Patients with malabsorpion syndrome ( celiac disease, crohn's , celiac disease )
- Patients with chronic respiratory acidosis (asthma, COPD, pulmonary fibrosis, neuromuscular disorders)
- Patients with diarrhea
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1-Change in serum chloride levels before and after fluid resucitation in DKA patients. 2- change in anion gap level before and after fluid resuscitation in DKA patients.
Time Frame: 2 years
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2 years
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Serum chloride in DKA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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