The Furosemide Stress Test, Electrolytes Response and Renal Index in Critically Ill Patients

NCT04215419 | Completed

• 1 other identifier: 2019/ST/094
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the present study is to compare the response to furosemide stress test in term of diuresis and electrolytes and of the renal index in mechanically ventilated patients at admission and after 3 days in patients with and without the presence of AKI

Conditions

Acute Kidney Injury

Keywords

Kidney; Furosemide; Renal Index; Stress Test; sodium; Potassium; Chloride

Outcome Measures

Primary Outcomes (2)

• Response to furosemide stress test in patients with and without AKI

  Urine volume after furosemide administration,

  Two hours after furosemide stress test

• Urine output of sodium, potassium and chloride after furosemide stress test

  Determination of Urinary Sodium concentration (meq/L)

  Two hours after furosemide stress test

Secondary Outcomes (1)

• Renal Index in patients with and without AKI

  At admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive mechanically ventilated patients, following an hemodynamic stabilization (mean arterial pressure of at least 65 mmHg without the need for fluid bolus and/or start or increase in the dose of vasopressors or inotropic drugs within the last 6 h), admitted to the General Intensive Care of Santi PaoloCarlo Hospital

You may qualify if:

• all mechanically ventilated patients

You may not qualify if:

• age \< 18 years
• pregnancy
• hemodynamic instability (defined as mean arterial pressure (MAP)\<60 mmHg)
• suspected or confirmed obstructive renal failure,
• presence of a chronic renal failure, as defined by a basal creatinine clearance value \< 30 ml min-1

Sponsors & Collaborators

• Hospital San Paolo: lead

Study Sites (1)

ASST Santi Paolo Carlo Ospedale San Paolo

Milan, 20152, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine sample

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Davide Chiumello, Professor

  ASST Santi Paolo e Carlo, ospedale San Paolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 2, 2020
• Study Start: July 24, 2019
• Primary Completion: October 20, 2019
• Study Completion: December 20, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)