跳至主要内容
临床试验/CTRI/2024/12/078229
CTRI/2024/12/078229招募中不适用

A prospective, two arm, observational study to analyze the factors predicting the role of double J stenting technique in management of acute pyelonephritis.

Bhaktivedanta Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月6日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
To analyse the factors determining the need for DJ stenting in patients with Acute Pyelonephritis.

研究概览

简要总结

Acute pyelonephritis (APN) is a severe, complicated urinary tract infection caused by the ascent of enteric bacteria, primarily Escherichia coli, from the bladder to the kidneys. It presents with systemic symptoms like fever, chills, and malaise, along with urinary symptoms such as frequency, urgency, and dysuria. Despite its global prevalence, particularly among women, and significant morbidity, epidemiological data on its incidence and causative organisms remain limited. The study aims to analyze factors determining the need for Double J (DJ) stenting in APN management and to evaluate the clinical profile and predisposing factors in these patients.

Inclusion Criteria: Adults aged ≥18 years diagnosed with APN and consenting to participate. Exclusion Criteria: Patients with pyonephrosis, perinephric/renal abscess, emphysematous pyelonephritis, requiring percutaneous nephrostomy or external drainage, or pregnant females.

Data collection will include demographic details, comorbidities, urological history, clinical symptoms, and blood investigations (CBC, RFT, RBS, HbA1c, cultures). Monitoring will cover key parameters such as fever, tachycardia, and renal function from admission to discharge.

The study will recruit patients over one year, with endpoints focusing on clinical and diagnostic factors predicting the need for DJ stenting.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 98.00 Year(s)(—)
性别
All

入选标准

  • 1 Patients of all genders above 18 years of age 2 All patients admitted with diagnosis of Acute Pyelonephritis.
  • 3 Patients giving consent for taking part in the study.

排除标准

  • 1 Patients with Pyonephrosis, Perinephric Abscess and Renal Abscess.
  • 2 Pregnant females.
  • 3 All patients with admitted with diagnosis of Emphysematous Pyelonephritis.
  • 4 Patients who needed Percutaneous nephrostomy.
  • 5 Patients who needed an external drainage of collection.
  • 6 Patients who do not consent to participate in the study.

结局指标

主要结局

To analyse the factors determining the need for DJ stenting in patients with Acute Pyelonephritis.

时间窗: At baseline, at 24 hours, at 48 hours within the diagnosis of acute pyelonephritis

次要结局

  • To analyse the clinical profile of patients with Acute Pyelonephritis.(To analyse the predisposing factors associated in patients with Acute Pyelonephritis.)

研究者

发起方
Bhaktivedanta Hospital and Research Institute
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Vikash Kumar

Bhaktivedanta Hospital and Research Institute

研究点 (1)

Loading locations...

相似试验