Clinical trial NCT06601374: Patient Presented With AKI Related to Pregnancy
Official title: Characteristics and Outcomes of Patients With Pregnancy Related Acute Kidney Injury in Assiut University Hospitals: a Single-center Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Kidney Injury
Keywords: AKI related to pregnancy
AKI
PRAKI
Pregnancy related AKI
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female presented with AKI related to pregnancy

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 (\&gt; 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.

Eligibility criteria: Inclusion Criteria:

* Women (\&gt;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 \&gt; 0.3 mg/dl within 48
  2. Increase in serum creatinine \&gt; 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days.
  3. urine volume of \&lt; .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

Primary outcomes:
measure: The occurance of renal recovery
timeFrame: After the insult and up to the subsequent 3 month duration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut university _ faculty of medicine
name: Mahmoud Saber, MBBCH
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut university _ faculty of medicine
name: Mahmoud Ali, MBBCH
role: STUDY_DIRECTOR
References: