Which of the following is not considered goal directed therapy for cardiogenic shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Sponsor:

Collaborator:

Information provided by (Responsible Party):

Ludhmila Abrahão Hajjar MD, PhD, University of Sao Paulo

• Study Details
• Tabular View
• No Results Posted
• Disclaimer
• How to Read a Study Record

Brief Summary:

Circulatory shock occurs when the supply of oxygen in the tissues decreases, which leads to cell damage and affects about one third of patients admitted to Intensive Care Units (ICU). Cardiac Output (CO) can be defined as the volume of blood ejected by the left ventricle per minute and is a very useful hemodynamic parameter in the monitoring of patients with signs of circulatory shock, since it can help define the etiology and management of such patients. Nevertheless, this parameter is underused in patients treated in Emergency Units, as its measurement usually involves invasive methods and few are available in this scenario. The pulmonary artery catheter is considered the gold standard method for determining the cardiac output, however, since it is an invasive method, in recent decades other devices capable of providing this hemodynamic variable in a less invasive way have been developed. Any method capable of providing CO without the need for pulmonary artery catheter insertion is called minimally invasive CO monitoring. The potential advantages of using these methods include the simplicity of measurements, faster acquisition of hemodynamic parameters and the possibility of implementing a monitoring strategy in places such as emergencies and emergency rooms. The evaluation of these parameters allows a faster determination of the etiology of circulatory shock, which enables the early initiation of goal-guided therapy. It is known that the use of goal-guided therapy proved to be effective in reducing peri- and postoperative morbidity and mortality in patients with high surgical risk; this strategy is also associated with reduced mortality, length of stay in the ICU and on mechanical ventilation in patients admitted to the ICU who are fluid responsive. To date, there is no data regarding the impact of a hemodynamic optimization strategy on patients in the first hours of shock. The investigators aim to assess whether goal-based hemodynamic therapy, through non-invasive hemodynamic monitoring, reduces the incidence of acute renal failure in patients with circulatory shock. A multicenter, randomized, open-label study will be carried out. The study will include patients over 18 years of age with signs of shock (systolic blood pressure less than 90 mmHg and/or mean arterial pressure less than 70 mmHg plus at least one of the following changes: lactate greater than 15 mg/dL, oliguria, neurological changes, and capillary refill time greater than 3 seconds) and who have signed an informed consent form (ICF). Included patients will be randomized in a 1:1 ratio into two groups. The Goal-Directed Therapy Group will be the one in which patients will be monitored by the ClearSight™ System (Edwards Life Sciences, Irvine, CA, USA) in the first 24 hours after randomization, where the parameters cardiac index (CI), systolic volume (SV), systolic blood pressure (SBP) and mean arterial pressure (MAP) will be used to determine medical management; if the CI is less than 2.2 L/min/m² and the SV less than 35 mL/beat, an aliquot of 500 mL of crystalloid solution will be administered; if the patient presents with CI less than 2.2 L/min/m², associated with SV greater than 35 mL/beat, dobutamine will be initiated; in patients with SBP less than 90 mmHg and/or MAP less than 70 mmHg, associated with SV greater than or equal to 35 mL/beat, norepinephrine will be initiated. In the Conventional Therapy group, the allocated patients will be treated according to the assistant team, where the following parameters will be evaluated: blood pressure, peripheral oximetry, heart rate, respiratory rate, and urine output; patients showing signs of hypovolemia will receive crystalloid solution; those who remain with hypotension refractory to volume replacement will be given vasoactive drugs; those with suggestive of cardiogenic shock will be given inotropic drugs; these procedures will be determined according to the clinical judgment of the assistant team.

Resource links provided by the National Library of Medicine

Primary Outcome Measures :

1. Number of Participants with Acute Kidney Injury [ Time Frame: 72 hours ]

   According to the AKIN classification, acute kidney injury is defined as an abrupt reduction (within 72 hours) in renal function, characterized by an absolute creatinine elevation greater than or equal to 0.3 mg/dL; or a percentage increase in creatinine greater than or equal to 50% (1.5 times baseline creatinine); or a reduction in urine output to less than 0.5 mL/Kg/h for six hours or more.

   
   

Secondary Outcome Measures :

1. Number of Participants with Myocardial Injury [ Time Frame: 30 days ]

   Presence of elevated troponin levels to values above the 99th percentile.

   
   
2. Number of Participants with Acute Myocardial Infarction [ Time Frame: 30 days ]

   Presence of Myocardial Injury, associated with at least one of the following factors:

   • Symptoms of acute myocardial ischemia;
   • Dynamic alteration on Electrocardiogram;
   • Evidence of new myocardial segmental contractility loss, diagnosed by Echocardiogram and/or Cardiac Resonance.
   
   
3. Number of Participants with need for invasive Intra Aortic Balloon-type [ Time Frame: 30 days ]

   Intra aortic balloon is a short term ventricular assist device, indicated in cases of cardiogenic shock refractory to the use of high doses of inotropic drugs.

   
   
4. Assessment of health costs [ Time Frame: 1 year ]

   The health costs will be measured in US dollars using the Brazilian Public Health database, which contains data on procedures, medicines, and hospital stay prices.

   
   
5. SOFA (Sequential Organ Failure Assessment) score [ Time Frame: 1st, 3rd, 7th and 30th day of hospital admission ]

   The SOFA score (Sequential Organ Failure Assessment score) is a scale composed of 6 parameters (PaO2/FiO2; Glasgow Coma Scale; mean arterial pressure (MAP) or administration of vasopressors required; bilirubin; platelets and creatinine or urine output), with a final value ranging between 0 and 24, where higher values indicate worsening of organ dysfunction.

   
   
6. Assessment of finger capillary refill time [ Time Frame: 1st, 3rd, 7th and 30th day of hospital admission ]

   The use of the ClearSight™ System monitor (Edwards Life Sciences, Irvine, CA, USA) can cause a decrease in the peripheral perfusion of the involved finger, therefore, the capillary refill time in seconds of the fingers of all involved patients will be evaluated (where a greater filling time shows worse peripheral perfusion), to observe if there is a difference between the protocol groups.

   
   
7. Number of Participants needing Mechanical Ventilation [ Time Frame: 30 days ]
   
8. Number of Participants needing Vasopressors [ Time Frame: 30 days ]
   
9. Number of Participants needing Inotropics [ Time Frame: 30 days ]
   
10. Length of hospital stay [ Time Frame: 30 days ]
    
11. Length of stay in the Intensive Care Unit [ Time Frame: 30 days ]
    
12. Number of Participants with need for Renal Replacement Therapy [ Time Frame: 30 days ]
    
13. Venous blood glucose measurement [ Time Frame: 1st, 3rd, 7th and 30th day of hospital admission ]

    Venous blood glucose will be measured using an enzymatic method (glucose dehydrogenase).

    
    
14. Quality of life assessment [ Time Frame: Hospital admission and at 30 days ]

    The assessment of quality of life will be made using the EQ-5D Dimensions questionnaire (EQ-5D), which consists of an instrument that assesses five dimensions (mobility, personal care, usual activities, pain/discomfort and anxiety/depression), where the patient indicates the degree of impairment in each dimension, in addition to a visual scale that varies from zero to one hundred, in relation to their perception of health on the day of the test, with one hundred indicating the best possible level of health, and zero indicating the worst possible level. This questionnaire was validated for use in the Brazilian population.

    
    
15. Rate of mortality [ Time Frame: 30 days, 6 months and 1 year ]
    

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Inclusion Criteria:

• Age > 18 years;
• Patients with shock defined as:

Systolic Blood Pressure (SBP) < 90 mmHg and/or Mean Arterial Pressure (MAP) < 70 mmHg and

At least one of the following alterations:

• Lactate > 18 mg/dL;
• Oliguria (diuresis < 0.5 mL/Kg/min for at least 6 hours);
• Neurological alteration (mental confusion, lowered level of consciousness, psychomotor agitation, temporal-spatial disorientation);
• Capillary refill time > 3 s (after 10 seconds of fingertip compression).

Exclusion Criteria:

• Significant edema in the fingers;
• Significant peripheral vasoconstriction;
• Use of Noradrenaline at a dose greater than or equal to 0.2 mcg/Kg/min;
• Presence of Aortic Insufficiency;
• Patients on Renal Replacement Therapy;
• Patients with acute ST-elevation Myocardial Infarction;
• Patients in need of Invasive Mechanical Ventilation;
• Patients already participating in another study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05336357

Layout table for location information

University of Sao Paulo

Instituto Dante Pazzanese de Cardiologia

Layout table for investigator information

Cecconi M, De Backer D, Antonelli M, Beale R, Bakker J, Hofer C, Jaeschke R, Mebazaa A, Pinsky MR, Teboul JL, Vincent JL, Rhodes A. Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Dec;40(12):1795-815. doi: 10.1007/s00134-014-3525-z. Epub 2014 Nov 13.

De Backer D, Bakker J, Cecconi M, Hajjar L, Liu DW, Lobo S, Monnet X, Morelli A, Myatra SN, Perel A, Pinsky MR, Saugel B, Teboul JL, Vieillard-Baron A, Vincent JL. Alternatives to the Swan-Ganz catheter. Intensive Care Med. 2018 Jun;44(6):730-741. doi: 10.1007/s00134-018-5187-8. Epub 2018 May 3. Review.

Teboul JL, Saugel B, Cecconi M, De Backer D, Hofer CK, Monnet X, Perel A, Pinsky MR, Reuter DA, Rhodes A, Squara P, Vincent JL, Scheeren TW. Less invasive hemodynamic monitoring in critically ill patients. Intensive Care Med. 2016 Sep;42(9):1350-9. doi: 10.1007/s00134-016-4375-7. Epub 2016 May 7.

Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MP, Ahern A, Griggs K, Scott R, Hinds C, Rowan K; OPTIMISE Study Group. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014 Jun 4;311(21):2181-90. doi: 10.1001/jama.2014.5305. Erratum in: JAMA. 2014 Oct 8;312(14):1473.

Osawa EA, Rhodes A, Landoni G, Galas FR, Fukushima JT, Park CH, Almeida JP, Nakamura RE, Strabelli TM, Pileggi B, Leme AC, Fominskiy E, Sakr Y, Lima M, Franco RA, Chan RP, Piccioni MA, Mendes P, Menezes SR, Bruno T, Gaiotto FA, Lisboa LA, Dallan LA, Hueb AC, Pomerantzeff PM, Kalil Filho R, Jatene FB, Auler Junior JO, Hajjar LA. Effect of Perioperative Goal-Directed Hemodynamic Resuscitation Therapy on Outcomes Following Cardiac Surgery: A Randomized Clinical Trial and Systematic Review. Crit Care Med. 2016 Apr;44(4):724-33. doi: 10.1097/CCM.0000000000001479.

Nowak RM, Nanayakkara P, DiSomma S, Levy P, Schrijver E, Huyghe R, Autunno A, Sherwin RL, Divine G, Moyer M. Noninvasive hemodynamic monitoring in emergency patients with suspected heart failure, sepsis and stroke: the PREMIUM registry. West J Emerg Med. 2014 Nov;15(7):786-94. doi: 10.5811/westjem.2014.8.21357. Epub 2014 Sep 23.

Keywords provided by Ludhmila Abrahão Hajjar MD, PhD, University of Sao Paulo:

Additional relevant MeSH terms:

Layout table for MeSH terms

What are goal directed therapy for cardiogenic shock?

What are the treatments for cardiogenic shock?

What is the first line treatment for cardiogenic shock?

Is Pericardiocentesis used in cardiogenic shock?