Electrolytes Disturbances in Critically Ill Egyptian Patients

NCT ID: NCT06097104

Last Updated: 2024-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-26

Study Completion Date

2024-08-08

Brief Summary

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All selected individuals will be subjected to the following:

1. Full medical history taking
2. Full clinical examination, APACHE II score on admission
3. Electrolytes panel daily on ICU admission
4. Estimate the duration of stay at ICU Also all selected individuals will be sectioned into groups regarding sites of collection (surgical ICU, CCU and medical ICU). All collected individuals will be sectioned regarding electrolytes imbalance into mild, moderate and severe groups

Detailed Description

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Study Procedures: All selected individuals will be suffering from electrolyte imbalance (EI) with the following data will be obtained:

o Measurements:

1. Demographic data: age - gender - BMI - electrolytes data on ICU admission
2. Vital data: heart rate - respiratory rate - blood pressure measurement - Oxygen saturation - Urinary output - Temp +/- CVP measurement.
3. Lab.: "CBC - Kidney function tests - liver function tests - ABG - levels of serum sodium, potassium, magnesium, phosphorus, ionized calcium and chloride", with maximum 5 mm blood sampling per day. Serum-sodium levels will be corrected for serum-glucose by lowering the sodium concentration by 2.4 mmol/L for every 100 mg/dl increase in glucose. Corrected Sodium = Measured sodium + 0.016 (Serum glucose - 100) A correction formula was also used to calculate albumin-corrected calcium levels (mmol/L) Corrected Calcium = (0.8 (Normal Albumin - Pt's Albumin)) + Serum Ca
4. APACHE II score
5. Comorbidities
6. Complications: AKI- Acute myocardial infarction
7. Duration of ICU stay
8. Duration of hospital stay
9. Outcome (regarding eventual complications: AKI- Acute myocardial infarction)

Conditions

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Electrolyte Imbalance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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electrolytes - serum blood samples

CBC - Kidney function tests - liver function tests - ABG - levels of serum sodium, potassium, magnesium, phosphorus, ionized calcium and chloride", with maximum 5 mm blood sampling per day

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- All patients admitted to medical ICU, surgical ICU and CCU suffering from electrolyte imbalance (EI) over 18 years with the comorbid conditions :

1. Hypertension
2. Heart failure
3. Chronic chest diseases
4. Cancers
5. Chronic kidney disease
6. Diabetes mellitus
7. Cardiac dysrhythmias
8. Pneumonia
9. Sepsis
10. Dehydration
11. Critical bones fractures

Exclusion Criteria

* Patients with

1. Age less than 18 year old
2. Patient or his 1st degree relatives refuse to participate
3. Patients without electrolytes data
4. Current smoking
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Sadek, MD candidate

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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FMASU MD195/2023

Identifier Type: -

Identifier Source: org_study_id

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