Diabetic KetoacidosisNCT05867797
Risk Factors and Outcomes of Acute Kidney Injury in Patients With Diabetic Ketoacidosis at Sohag University Hospital.
An observational study of Diabetic Ketoacidosis and Acute Kidney Injury, run by Sohag University.
Trial summary
Diabetic ketoacidosis (DKA), a severe complication of diabetes mellitus (DM), is the leading cause of hospitalization, morbidity and mortality in patients with DM (1). DKA is associated with hyperglycemic crises and featured by metabolic acidosis, the production of ketoacids, volume depletion, and electrolyte… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Ketoacidosis, Acute Kidney Injury
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2023to 20 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic ketoacidosis at Sohag university hospital for all patients admitted during the period from May 2023 to May 2024
Who may be able to join
- patients will be included in this study aged >18 years old after diagnosis of AKI on top of Diabetic ketoacidosis at Sohag university hospital for all patients admitted during the period from May 2023 to May 2024
Who cannot join
- Chronic kidney disease
Trial locations and contacts
No sites are listed yet.
About this study
Diabetic ketoacidosis (DKA), a severe complication of diabetes mellitus (DM), is the leading cause of hospitalization, morbidity and mortality in patients with DM (1).
DKA is associated with hyperglycemic crises and featured by metabolic acidosis, the production of ketoacids, volume depletion, and electrolyte imbalance. Due to glucose-induced osmotic polyuria and even emesis, volume depletion is a major cause of acute kidney injury (AKI) in DKA patients (2).
- Conditions
- Diabetic Ketoacidosis, Acute Kidney Injury
- Keywords
- DKA AKI
- Medical subject headings
- Diabetic Ketoacidosis, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
prognosis risk factors and outcomes of AKI in patients with DKA
complete resolution or progress to CKD or mortality and discover risk factors for AKI as uncontrolled diabetes infection or high uric acid uncontrolled hyperlipidemia
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start20 May 2023 (estimated)
- Primary completion20 May 2024 (estimated)
- Study completion20 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahraa Abdelaal Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867797
- Sponsor's protocol ID
- Soh-Med-23-05-03MD
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Outcomes of Acute Kidney Injury in Patients With Diabetic Ketoacidosis at Sohag University Hospital.
- ClinicalTrials.gov ID
- NCT05867797
- Acronym / sponsor ID
- Soh-Med-23-05-03MD
- Conditions
- Diabetic Ketoacidosis, Acute Kidney Injury
- Keywords
- DKA AKI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (estimated)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetic ketoacidosis (DKA), a severe complication of diabetes mellitus (DM), is the leading cause of hospitalization, morbidity and mortality in patients with DM (1).
DKA is associated with hyperglycemic crises and featured by metabolic acidosis, the production of ketoacids, volume depletion, and electrolyte imbalance. Due to glucose-induced osmotic polyuria and even emesis, volume depletion is a major cause of acute kidney injury (AKI) in DKA patients (2).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic ketoacidosis at Sohag university hospital for all patients admitted during the period from May 2023 to May 2024
Key inclusion criteria (1 listed)
- patients will be included in this study aged >18 years old after diagnosis of AKI on top of Diabetic ketoacidosis at Sohag university hospital for all patients admitted during the period from May 2023 to May 2024
Key exclusion criteria (1 listed)
- Chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prognosis risk factors and outcomes of AKI in patients with DKA
Time frame: 1 YEAR
complete resolution or progress to CKD or mortality and discover risk factors for AKI as uncontrolled diabetes infection or high uric acid uncontrolled hyperlipidemia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Ketoacidosis and Acute Kidney Injury, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zahraa Abdeaal Ahmed (01028201984, Zahraa.abdalah@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prognosis risk factors and outcomes of AKI in patients with DKA (time frame: 1 YEAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.