NCT06601374

Brief Summary

The primary objective of this study is to identify characteristics of patient with PR AKI treated in Assiut university hospital Secondary outcomes:

  1. 1.Assessment of pregnancy related AKI maternal outcome (complete recovery , partial recovery or progress to ESRD) within 3 months duration
  2. 2.To identify predictors of unfavorable outcome of patient with pregnancy related AKI

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

September 11, 2024

Last Update Submit

September 18, 2024

Conditions

Keywords

AKI related to pregnancyAKIPRAKIPregnancy related AKI

Outcome Measures

Primary Outcomes (1)

  • 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

    After the insult and up to the subsequent 3 month duration

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female presented with AKI related to pregnancy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Mahmoud Saber, MBBCH

    Assiut university _ faculty of medicine

    PRINCIPAL INVESTIGATOR
  • Mahmoud Ali, MBBCH

    Assiut university _ faculty of medicine

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MBBCH , principal investigator

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09