Clinical Trial: Simple Intensive Care Studies I (SICS-I)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Combining Conventional With Advanced Hemodynamic Parameters for Predicting the Outcome of Critically Ill Patients: a Pilot for a Registry

Brief Summary:

Circulatory shock is a condition of generalized inadequate blood flow through the body, leading to insufficient tissue perfusion and inadequate delivery of oxygen and other nutrients, to the extent that tissues are damaged. Four basic mechanisms of circulatory failure are distinguished, caused by a scale of underlying illnesses: distributive, hypovolemic, obstructive and cardiogenic shock. The last three types are characterized by a low cardiac output and hypovolemia. Distributive shock is characterized by peripheral circulation failure, with a low systemic vascular resistance, a disturbed microcirculation and a high cardiac output. Frequently, these forms overlap.

Shock is a common problem in the intensive care unit (ICU) as it affects about one third of the patients. Septic shock appears to be the most common type, followed by cardiogenic and hypovolemic shock. The diagnosis of shock is based on clinical examination with use of well-known circulatory parameters such as blood pressure and heart rate; biochemical parameters such as lactate and direct (semi-)invasive measurement of cardiac output and other variables.

Since cardiac output is an important determinant of oxygen delivery, many different methods of measuring cardiac output have been suggested. These methods range from non-invasive to invasive measurements with central lining. The most invasive method, the pulmonary artery catheter (PAC) has long been considered the optimal form of monitoring cardiac output by using thermodilution. However, this technique is associated with adverse events, such as bleeding, and there is no clear evidence of improved outcome. Therefore, numerous other techniques have been proposed, ranging from systems that use the dilution technique but only require central venous and peripheral artery lines; to less invasive tools that estimate

Detailed Summary:

Registry procedures:

Eligible patients will be included within 24 hours after their arrival on the Intensive Care Unit. After inclusion all study parameters will be obtained once through physical examination combined with transthoracic echocardiography. Mortality will be assessed at 7 days after admission. In addition, mortality will be estimated at 30 and 90 days after admission.

Monitoring:

Monitoring will be performed by independent researchers of the department of anaesthesiology of the UMCG. Audits are planned to take place once a year.

Quality assurance plan:

Recruitment:

Inclusion of patients and measurements of variables (both conventional hemodynamic variables and cardiac output) will be performed by the study coordinator or a co-researcher under supervision and responsibility of the principle investigator. Informed consent will be obtained.

Source data verification:

At inclusion all conventional hemodynamic variables are derived by physical examination and recording data from the basic hemodynamic monitoring (Philips ImageVue monitor with tracing of heart rate, electrocardiogram (ECG), SpO2, arterial pressure from arterial line pressure measurement and/or from non-invasively blood pressure monitoring). In addition, a transthoracic echocardiography (TTE) will be performed to non-invasively determine the cardiac output by using the diameter of the aortic annulus, the velocity time integral (VTI) of the Doppler flow and the heart rate. All variables are predefined (see data dictionary) to standardize all measurements by s
Sponsor: University Medical Center Groningen

Current Primary Outcome: The association between conventional hemodynamic parameters with cardiac output [ Time Frame: Immediately ]

To investigate which combination of all hemodynamic parameters obtainable through physical examination are associated with cardiac output measured by transthoracic echocardiography


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The association between hemodynamic parameters and 7 day mortality [ Time Frame: 7 days ]
  • The association between hemodynamic parameters and 30 day mortality [ Time Frame: 30 days ]
  • The association between hemodynamic parameters and 90 day mortality [ Time Frame: 90 days ]


Original Secondary Outcome: Same as current

Information By: University Medical Center Groningen

Dates:
Date Received: September 21, 2016
Date Started: March 2015
Date Completion: March 2018
Last Updated: September 23, 2016
Last Verified: September 2016