Acute Kidney InjuryNCT06601374
Patient Presented With AKI Related to Pregnancy
An observational study of Acute Kidney Injury, run by Assiut University.
Trial summary
The primary objective of this study is to identify characteristics of patient with PR AKI treated in Assiut university hospital Secondary outcomes: 1. Assessment of pregnancy related AKI maternal outcome (complete recovery , partial recovery or progress to ESRD) within 3 months duration 2. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Dec 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female presented with AKI related to pregnancy
Who may be able to join
- Women (\>18 years) who developed AKI with or without need for dialysis treatment during pregnancy, childbirth , post abortion period and /or puerperium
- AKI as defined by KDIGO definition as follows:
- Increase in serum creatinine \> 0.3 mg/dl within 48
- Increase in serum creatinine \> 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days.
- urine volume of \< .5 ml / kg / hours
Who cannot join
- Patients with preexisting kidney disease before pregnancy
- Patients with AKI not related to pregnancy.
- Patients with uncertain history for incident time of AKI.
- Patients refuse to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Characteristics and Outcomes of Patients With Pregnancy Related Acute Kidney Injury in Assiut University Hospitals: a Single-center Study
The primary objective of this study is to identify characteristics of patient with PR AKI treated in Assiut university hospital
Secondary outcomes:
- Assessment of pregnancy related AKI maternal outcome (complete recovery , partial recovery or progress to ESRD) within 3 months duration
- To identify predictors of unfavorable outcome of patient with pregnancy related AKI
Read the detailed description
Acute kidney Injury (AKI) is a syndrome which is characterized by an rapid deterioration of the kidney function , manifested by increase in serum creatinine level with or without reduced urine output and linked to high rate of morbidity and mortality .AKI is considered a major public health problem despite much improvmnent in heakth care and especially, most of them (about 85 %) in developing countries with low resources.Pregnancy related AKI ( PR -AKI ) is a major obstetric complication which may cause termination of pregnancy (TOP ), Intensive care unit ( ICU ) admission , need for dialysiy , both maternal and perinatal morbidity and mortality with maternal mortality rang from 9% to 55 % .
PR-AKI has a major risk factors include preeclampsia which is the most common cause (15-20%) , hyperemesis gravidarum , acute fatty liver of pregnancy and placental abruption , puerperal sepsis and septic abortion .The maternal outcome of pregnancy related AKI include complete recovery with return of serum creatinine to normal (\> 1.4 mg /dl ) about (40-75% ), partial recovery(4-9% require dialysis about 4 months after delivery) , progress to End stage renal disease (1.5 - 2.5 %) or maternal mortality . The maternal mortality rate (MMR) increases with increasing severity of pregnancy-related complications and can range from 13 to 24% in developing countries due to PR-AKI .
Timely identification of patients and management of underlying conditions is considered the cornerstone to improve maternal outcome.
- Conditions
- Acute Kidney Injury
- Keywords
- AKI related to pregnancy, AKI, PRAKI, Pregnancy related AKI
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurance of renal recovery
The occurance of renal recovery measured by serum creatinine , eGFR , urinary proteins and need for dialysis after the insult and up to the subsequent 3 month duration
Measured: After the insult and up to the subsequent 3 month duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Saber Mohamed Ali, Assiut University
- Investigators
- Mahmoud Saber, MBBCH, Principal investigator, Assiut university _ faculty of medicineMahmoud Ali, MBBCH, Study director, Assiut university _ faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601374
- Sponsor's protocol ID
- Pregnancy related AKI
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Outcomes of Patients With Pregnancy Related Acute Kidney Injury in Assiut University Hospitals: a Single-center Study
- ClinicalTrials.gov ID
- NCT06601374
- Acronym / sponsor ID
- Pregnancy related AKI
- Conditions
- Acute Kidney Injury
- Keywords
- AKI related to pregnancy, AKI, PRAKI, Pregnancy related AKI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
The primary objective of this study is to identify characteristics of patient with PR AKI treated in Assiut university hospital
Secondary outcomes:
- Assessment of pregnancy related AKI maternal outcome (complete recovery , partial recovery or progress to ESRD) within 3 months duration
- To identify predictors of unfavorable outcome of patient with pregnancy related AKI
Detailed description
Acute kidney Injury (AKI) is a syndrome which is characterized by an rapid deterioration of the kidney function , manifested by increase in serum creatinine level with or without reduced urine output and linked to high rate of morbidity and mortality .AKI is considered a major public health problem despite much improvmnent in heakth care and especially, most of them (about 85 %) in developing countries with low resources.Pregnancy related AKI ( PR -AKI ) is a major obstetric complication which may cause termination of pregnancy (TOP ), Intensive care unit ( ICU ) admission , need for dialysiy , both maternal and perinatal morbidity and mortality with maternal mortality rang from 9% to 55 % .
PR-AKI has a major risk factors include preeclampsia which is the most common cause (15-20%) , hyperemesis gravidarum , acute fatty liver of pregnancy and placental abruption , puerperal sepsis and septic abortion .The maternal outcome of pregnancy related AKI include complete recovery with return of serum creatinine to normal (\> 1.4 mg /dl ) about (40-75% ), partial recovery(4-9% require dialysis about 4 months after delivery) , progress to End stage renal disease (1.5 - 2.5 %) or maternal mortality . The maternal mortality rate (MMR) increases with increasing severity of pregnancy-related complications and can range from 13 to 24% in developing countries due to PR-AKI .
Timely identification of patients and management of underlying conditions is considered the cornerstone to improve maternal outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female presented with AKI related to pregnancy
Key inclusion criteria (5 listed)
- Women (\>18 years) who developed AKI with or without need for dialysis treatment during pregnancy, childbirth , post abortion period and /or puerperium
- AKI as defined by KDIGO definition as follows:
Key exclusion criteria (4 listed)
- Patients with preexisting kidney disease before pregnancy
- Patients with AKI not related to pregnancy.
- Patients with uncertain history for incident time of AKI.
- Patients refuse to participate in the study
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
The occurance of renal recovery
Time frame: After the insult and up to the subsequent 3 month duration
The occurance of renal recovery measured by serum creatinine , eGFR , urinary proteins and need for dialysis after the insult and up to the subsequent 3 month duration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Mahmoud Saber, MBBCH principal investigator
Assiut university _ faculty of medicine
Mahmoud Ali, MBBCH study director
Assiut university _ faculty of medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Assiut 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 5 inclusion and 4 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 19 Sep 2024. 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 Mahmoud Saber, MBBCH (+201017548181, Mahmoud.16266142@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurance of renal recovery (time frame: After the insult and up to the subsequent 3 month duration). 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 19 Sep 2024.