Patient Presented With AKI Related to Pregnancy

NCT ID: NCT06601374

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-12-31

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. Assessment of pregnancy related AKI maternal outcome (complete recovery , partial recovery or progress to ESRD) within 3 months duration

2. 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.

Conditions

Acute Kidney Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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:

1. Increase in serum creatinine > 0.3 mg/dl within 48

2. Increase in serum creatinine > 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days.

3. urine volume of < .5 ml / kg / hours

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Saber Mohamed Ali

MBBCH , principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmoud Saber, MBBCH

Role: PRINCIPAL_INVESTIGATOR

Assiut university _ faculty of medicine

Mahmoud Ali, MBBCH

Role: STUDY_DIRECTOR

Assiut university _ faculty of medicine

Central Contacts

Mahmoud Saber, MBBCH

Role: CONTACT

Mahmoud.16266142@med.aun.edu.eg

+201017548181

Radwa Abdelrazek, MD

Role: CONTACT

Radwa.ellisy15@aun.edu.eg

+201006659537

Other Identifiers

Pregnancy related AKI

Identifier Type: -

Identifier Source: org_study_id