Time Course Evolution of Cardiac Output

NCT03694717 | Completed

• 1 other identifier: ADOREPS
• Study Type: observational
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fluid expansion is the first therapeutic option in patients presenting acute circulatory failure but the duration of its hemodynamic effects (persistency and time of maximal increase in cardiac output) is unknown. This study is seeking to describe in critically ill patients, the time course evolution of cardiac output over a 2-hours period after a fluid expansion. The objectives are:

1. 1.to identify patterns of fluid responsiveness
2. 2.to determine the time when the maximal increase in cardiac output occurs during and a after fluid expansion
3. 3.to compare patients' characteristics between patterns

Conditions

Acute Circulatory Failure

Keywords

shock; fluid expansion; fluid responsiveness

Outcome Measures

Primary Outcomes (1)

• Change in cardiac output during fluid expansion

  Difference between maximal cardiac output during fluid expansion and baseline

  10 minutes

Secondary Outcomes (1)

• Change in cardiac output after fluid expansion

  2 hours

Study Arms (1)

Patients

The patients will receive a 500 ml fluid expansion over a standardized 10 minutes period

Drug: Saline Solution for Injection

Interventions

Saline Solution for Injection DRUG

The fluid expansion will consist in a less than 10 min infusion of 500 milliliters of saline through a central venous catheter (jugular). The duration of infusion will be controlled by an airbag pressurized at 300 mmHg.

Patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients admitted in the intensive care unit receiving mechanical ventilation and presenting an acute circulatory failure.

You may qualify if:

• acute circulatory failure (infusion of norepinephrine)
• invasive mechanical ventilation through an endotracheal tube
• decision of fluid expansion
• extracorporeal membranous oxygenation (ECMO)
• active bleeding
• continuous renal replacement therapy with weight loss
• administration of diuretics within the past six hours
• decision of therapeutic limitation,
• age under eighteen years

You may not qualify if:

• hemodynamic instability after fluid expansion (mean arterial pressure \< 65mmHg)

Sponsors & Collaborators

• Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil: lead

Related Publications (1)

• Nunes TS, Ladeira RT, Bafi AT, de Azevedo LC, Machado FR, Freitas FG. Duration of hemodynamic effects of crystalloids in patients with circulatory shock after initial resuscitation. Ann Intensive Care. 2014 Aug 1;4:25. doi: 10.1186/s13613-014-0025-9. eCollection 2014.

  PMID: 25593742 RESULT

MeSH Terms

Conditions

Shock

Interventions

Saline Solution; Injections

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Martin Dres, MD, PhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 3, 2018
• Study Start: April 15, 2016
• Primary Completion: May 15, 2018
• Study Completion: May 31, 2018
• Last Updated: October 4, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share