Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05336357

The Effect of Non-invasive Hemodynamic Goal-directed Therapy on the Incidence of Acute Kidney Injury in Circulatory Shock: a Randomized Clinical Trial

Led by University of Sao Paulo · Updated on 2024-08-26

380

Participants Needed

1

Research Sites

35 weeks

Total Duration

On this page

Sponsors

U

University of Sao Paulo

Lead Sponsor

I

Instituto Dante Pazzanese de Cardiologia

Collaborating Sponsor

AI-Summary

What this Trial Is About

Circulatory shock is a condition where the body's tissues receive less oxygen, causing cell damage and affecting many patients admitted to Intensive Care Units. This trial focuses on patients with septic shock, a severe form of sepsis with low blood pressure and other critical signs. Researchers are evaluating whether using a non-invasive method to monitor heart function and guide treatment can speed up recovery compared to standard care in emergency and hospital settings. The study is multicenter, randomized, and open-label, involving adult patients over 18 years old. Participants will be divided into two groups. The Goal-Directed Therapy Group will be monitored using the ClearSight™ System, which continuously measures heart parameters such as cardiac index, stroke volume, and blood pressure for the first 24 hours. Treatment will be adjusted based on these values, including fluid infusions, vasoactive drugs, or inotropic medications as needed. The Conventional Therapy Group will receive usual care with standard monitoring tools, clinical examination, and laboratory tests, following guidelines for fluid resuscitation and medication use. During the study, participants will receive assessments including vital signs, clinical exams, and laboratory tests. Researchers will track how long it takes to achieve hemodynamic resuscitation within 6 hours, as well as other outcomes like kidney injury, heart complications, fluid amounts given, hospital stay length, quality of life, and mortality rates. Follow-up will extend up to 6 months for some outcomes, ensuring comprehensive monitoring of patient progress and safety throughout the trial.

CONDITIONS

Brief Title

Non-invasive Goal-directed thErapy oN cIrcUlatory Shock

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Admission to Emergency Units, Intensive Care Units, or Hospital Wards within 3 hours of septic shock diagnosis
  • Systolic blood pressure less than 90 mmHg and/or mean arterial pressure less than 65 mmHg (with or without norepinephrine dose less than 0.5 mcg/kg/min)
  • Clinical signs of infection plus at least one of the following: lactate over 2 mEq/L, oliguria (urine output less than 0.5 mL/kg/h for at least 6 hours), neurological changes, capillary refill time greater than 3 seconds, or poor skin perfusion
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Hospital admission time greater than 24 hours
  • Significant edema in the fingers
  • Severe peripheral vasoconstriction
  • Use of norepinephrine at a dose of 0.5 mcg/kg/min or higher
  • Presence of significant aortic insufficiency
  • Patients undergoing renal replacement therapy
  • Patients with ST-segment elevation myocardial infarction
  • Patients requiring invasive mechanical ventilation
  • Participation in another clinical study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 hours

Participants receive either goal-directed therapy with continuous non-invasive hemodynamic monitoring or conventional therapy according to standard emergency care for septic shock during the first 24 hours after randomization.

Continuous monitoring during treatment period

Follow-up

Duration - Up to 6 months

Participants are monitored for health outcomes including kidney injury, myocardial events, length of hospital stay, quality of life, health costs, and mortality over varying time frames up to 6 months after treatment.

Visits at hospital admission, 30 days, and additional assessments up to 6 months

Trial Site Locations

Total: 1 location

1

Instituto do Coração

São Paulo, Brazil, 05403-000

Actively Recruiting

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Research Team

L

Ludhmila A Hajjar, MD, PhD

A

ARO F InCor, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine.

Maurizio Cecconi, Daniel De Backer, Massimo Antonelli...

https://pubmed.ncbi.nlm.nih.gov/25392034

Does dopamine administration in shock influence outcome? Results of the Sepsis Occurrence in Acutely Ill Patients (SOAP) Study.

Yasser Sakr, Konrad Reinhart, Jean-Louis Vincent...

https://pubmed.ncbi.nlm.nih.gov/16505643

Auler JO Jr, Galas FR, Sundin MR, Hajjar LA: Arterial pulse pressure variation predicting fluid responsiveness in critically ill patients. Shock 30(Suppl 1):18-22, 2008.

Jose Otavio C Auler, Filomena R B G Galas, Marcia R Sundin...

https://pubmed.ncbi.nlm.nih.gov/19365234