Factors and Prognosis of Obstructive Pyelonephritis Patients (PYELO-OBS)

March 27, 2024 updated by: Assistance Publique - Hôpitaux de Paris

Factors Associated With the Prognosis of Patients Admitted to for Acute Obstructive Pyelonephritis

Acute obstructive pyelonephritis is a condition with a high risk of complications and may require admission to the intensive care unit.

Most of the available data on this condition comes from small, retrospective, single-centre series.

To date, no large-scale study has examined the factors associated with the prognosis of patients admitted to intensive care for acute obstructive pyelonephritis.

The aim of this study is to describe the population and prognosis of patients admitted to the intensive care unit for the management of acute obstructive pyelonephritis, and to identify factors associated with a poor prognosis in these patients.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The retrospective and multicenter study consists of a retrospective and pseudonymous collection of data from medical reports of patients treated, over the period 2015-2022, in each intensive care unit agreeing to participate, .

Investigators from each participating center will be responsible for screening on all hospitalized patients over the period 2015-2022. Patients who have been hospitalized for the management of acute obstructive pyelonephritis will be included, in the absence of non-inclusion criteria.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75010
        • Hospital Saint Louis
        • Contact:
          • Maxime Dr COUTROT, MD
        • Contact:
          • François DEPRET, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients meeting the eligibility criteria over the period 2015-2022 will be included in the study.

Description

Inclusion Criteria:

  • Patients over 18 years of age
  • Hospitalized in intensive care for management of acute obstructive pyelonephritis
  • Patients affiliated to a Social Security System

Exclusion Criteria:

  • Pregnancy
  • Opposition to data use
  • Persons under legal protection (curatorship, guardianship), legal safeguards

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint will be a combined endpoint of death, and/or stage 3 AKI ( KDIGO classification), and/or non-recovery of renal function.
Time Frame: up to 30 days after admission to intensive care
up to 30 days after admission to intensive care

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: up to 30 days after admission to intensive care
up to 30 days after admission to intensive care
Stage 3 Acute kidney injury (KDIGO classification)
Time Frame: up to 30 days after admission to intensive care
up to 30 days after admission to intensive care
failure to recover renal function
Time Frame: up to 30 days after admission to intensive care .
defined as creatinine levels greater than 150% of baseline value
up to 30 days after admission to intensive care .
the incidence of acute renal failure defined by KDIGO 1
Time Frame: up to 30 days after admission to intensive care
up to 30 days after admission to intensive care
the incidence of acute renal failure defined by KDIGO 2 and 3
Time Frame: up to 30 days after admission to intensive care
up to 30 days after admission to intensive care
the incidence of Renal replacement therapy
Time Frame: up to 30 days after admission to intensive care
up to 30 days after admission to intensive care
the incidence of non-recovery of renal fuction
Time Frame: up to 30 days after admission to intensive care
up to 30 days after admission to intensive care
The number of days alive without Renal replacement therapy
Time Frame: up to 30 days after admission to intensive care
up to 30 days after admission to intensive care
The number of days alive without catecholamines
Time Frame: up to 30 days after admission to intensive care
up to 30 days after admission to intensive care
The number of days alive without antibiotics
Time Frame: up to 30 days after admission to intensive care
up to 30 days after admission to intensive care
The number of days alive without
Time Frame: up to 30 days after admission to intensive care
up to 30 days after admission to intensive care
Death rate
Time Frame: up to 30 days after admission to intensive care
up to 30 days after admission to intensive care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Maxime Dr COUTROT, MD, Hopital saint Louis-APHP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP240044

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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