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NCT Number: NCT06601374

Patient Presented With AKI Related to Pregnancy

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Saber, MBBCH

CONTACT

[email protected]

+201017548181

Radwa Abdelrazek, MD

CONTACT

[email protected]

+201006659537

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Characteristics and Outcomes of Patients With Pregnancy Related Acute Kidney Injury in Assiut University Hospitals: a Single-center Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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