Simple Intensive Care Studies I (SICS-I)

NCT02912624 | Completed DMC

• 1 other identifier: 201500144
• Study Type: observational
• Target: 1,090
• Locations: 1 country
• Sites: 1

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 cardiac output based on the arterial pressure waveform; and to non-invasive echocardiography. Despite technical advances, much remains unknown about the value of conventionally used hemodynamic parameters for estimating cardiac output. A distinction between macro- and microcirculatory parameters can be made. Commonly used macro-circulatory parameters are heart rate, systolic and diastolic blood pressure, mean arterial pressure and central venous pressure. Lactate is used as a proxy for microcirculatory status. Over the years several other measurements have been suggested to improve insight in the hemodynamics of a certain patient or a group of patients. Skin temperature, capillary refill, mottling score and urinary output are used for hemodynamic assessment of the peripheral circulation and tissue perfusion. Most of these parameters have not been evaluated in a large prospective study and especially a combination of all these parameters has not directly been correlated to cardiac output. More knowledge on the predictive value of all hemodynamic parameters in estimating cardiac output could assist physicians in earlier detection of impaired hemodynamics without the need for invasive or advanced methods. In this study the investigators aim to evaluate all hemodynamic parameters in a large unselected population of critically ill patients and to correlate them to cardiac output. Purpose: The purpose of this study is to create an infrastructure for a registry flexible to incorporate temporarily added specific research questions on the outcome of critically ill patients.

Conditions

Critical Illness; Acute Disease; Shock

Keywords

Physical Examination; Diagnostic Imaging; Ultrasonography; Hemodynamics; Patient Outcome Assessment; Mortality

Outcome Measures

Primary Outcomes (2)

• The association of a single or combination of clinical examination findings with cardiac index measured with transthoracic ultrasonography

  Primary outcome of the basic study, answering our diagnostic research question We calculated cardiac index, which was derived from cardiac output. Cardiac output has been measured with the cardiac probe M3S of M4S with default cardiac imaging setting of the General Electric Vivid-S6 mobile ultrasound machine. Two views were obtained: the parasternal long axis (PLAX) and the apical five chamber view (AP5CH). The PLAX was used as the primary view to measure the left ventricular outflow tract (LVOT) diameter. The AP5CH view was used to measure the velocity time integral (VTI) using the pulse wave Doppler signal in the LVOT. Cardiac output was calculated on the ultrasound machine according to the formula: Cardiac output (L/min)=heart rate ∙VTI∙π∙(1/2∙LVOT)\^2 Clinical examination findings have been collected during a one-time physical examination, which is further specified at the study description section.

  Immediately

• The association of all measured clinical examination findings, biochemical values and hemodynamic variables measured with transthoracic echocardiography with 90-day mortality

  Primary outcome of the basic study, answering our prognostic research question. Clinical examination findings, as well are specified at the study description section. Biochemical values are serum lactate, creatinine and hemoglobine (see study description). Hemodynamic variables are obtained from advanced patient monitoring devices, such as invasive central venous or arterial blood pressures, echocardiographic measurements, etc. Follow-up on all-cause mortality will be obtained from the municipal personal records database. Analysis of mortality will be performed using time-to-event data (patients were censored at 90-days of follow-up).

  90 days

Secondary Outcomes (5)

• The diagnostic test accuracy of a single or a combination of clinical examination findings to diagnose a low, normal and high cardiac index measured with transthoracic echocardiography

  Immediately

• The association and diagnostic test accuracy of a single or combination of clinical examination findings with cardiac index in clinically different patient subgroups

  Immediately

• The association of clinical examination, biochemical and haemodynamic variables and 7- and 30-day mortality

  30 days

• The association of clinical examination, biochemical and haemodynamic variables that are not visible to caregivers with 90-day mortality

  90 days

• The association of clinical examination, biochemical and haemodynamic variables with 90-day mortality in clinically different patient subgroups

  90 days

Other Outcomes (28)

• The association between clinical, biochemical and haemodynamic variables and tissue (muscle) StO2 at the knee measured by near-infrared spectroscopy (NIRS) with the Inspectra StO2 tissue oxygenation monitor

  Immediately

• The association between clinical, biochemical and haemodynamic variables and tissue (muscle) StO2 at the thenar muscle measured by near-infrared spectroscopy (NIRS) with the Inspectra StO2 tissue oxygenation monitor

  Immediately

• The association between tissue (muscle) StO2 measured by NIRS and 90-day mortality

  Immediately

Eligibility Criteria

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

Study Population

The study will be conducted in the adult Critical Care of the University of Groningen, University Medical Center Groningen, a tertiary teaching hospital in the Northern part of the Netherlands.

You may qualify if:

• Emergency admission
• Expected stay \> 24 hours

You may not qualify if:

• Age \< 18 years
• Planned admission (either after surgery or for other reasons)
• Withdrawn or unable to obtain informed consent
• Continuous resuscitation efforts or mechanical circulatory support

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Related Publications (6)

• Hiemstra B, Eck RJ, Koster G, Wetterslev J, Perner A, Pettila V, Snieder H, Hummel YM, Wiersema R, de Smet AMGA, Keus F, van der Horst ICC; SICS Study Group. Clinical examination, critical care ultrasonography and outcomes in the critically ill: cohort profile of the Simple Intensive Care Studies-I. BMJ Open. 2017 Sep 27;7(9):e017170. doi: 10.1136/bmjopen-2017-017170.

  PMID: 28963297 BACKGROUND

• Cox EGM, Wiersema R, Eck RJ, Kaufmann T, Granholm A, Vaara ST, Moller MH, van Bussel BCT, Snieder H, Pleijhuis RG, van der Horst ICC, Keus F. External Validation of Mortality Prediction Models for Critical Illness Reveals Preserved Discrimination but Poor Calibration. Crit Care Med. 2023 Jan 1;51(1):80-90. doi: 10.1097/CCM.0000000000005712. Epub 2022 Nov 15.

  PMID: 36378565 DERIVED

• Cox EGM, Koster G, Baron A, Kaufmann T, Eck RJ, Veenstra TC, Hiemstra B, Wong A, Kwee TC, Tulleken JE, Keus F, Wiersema R, van der Horst ICC; SICS Study Group. Should the ultrasound probe replace your stethoscope? A SICS-I sub-study comparing lung ultrasound and pulmonary auscultation in the critically ill. Crit Care. 2020 Jan 13;24(1):14. doi: 10.1186/s13054-019-2719-8.

  PMID: 31931844 DERIVED

• Koster G, Kaufmann T, Hiemstra B, Wiersema R, Vos ME, Dijkhuizen D, Wong A, Scheeren TWL, Hummel YM, Keus F, van der Horst ICC. Feasibility of cardiac output measurements in critically ill patients by medical students. Ultrasound J. 2020 Jan 8;12(1):1. doi: 10.1186/s13089-020-0152-5.

  PMID: 31912438 DERIVED

• Kaufmann T, Castela Forte J, Hiemstra B, Wiering MA, Grzegorczyk M, Epema AH, van der Horst ICC; SICS Study Group. A Bayesian Network Analysis of the Diagnostic Process and Its Accuracy to Determine How Clinicians Estimate Cardiac Function in Critically Ill Patients: Prospective Observational Cohort Study. JMIR Med Inform. 2019 Oct 30;7(4):e15358. doi: 10.2196/15358.

  PMID: 31670697 DERIVED

• Kaufmann T, Clement RP, Hiemstra B, Vos JJ, Scheeren TWL, Keus F, van der Horst ICC; SICS Study Group. Disagreement in cardiac output measurements between fourth-generation FloTrac and critical care ultrasonography in patients with circulatory shock: a prospective observational study. J Intensive Care. 2019 Apr 11;7:21. doi: 10.1186/s40560-019-0373-5. eCollection 2019.

  PMID: 31011425 DERIVED

MeSH Terms

Conditions

Critical Illness; Acute Disease; Shock

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Iwan CC van der Horst, M.D., Ph.D.

  University of Groningen, University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 23, 2016
• Study Start: March 27, 2015
• Primary Completion: July 22, 2017
• Study Completion: November 1, 2017
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

NL (1)