Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201911842779294 Date of Registration: 15/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cardiometry in management of septic patients
Official scientific title Echo derived indices versus cardiometry in management of septic patients
Brief summary describing the background and objectives of the trial Sepsis is a systemic illness following invasion of the body by an infectious agent, to which the body reacts by releasing a storm of inflammatory mediators including cytokines, interleukins and many others, constituting the systemic inflammatory response syndrome (SIRS). Septic shock develops when sepsis affects the cardiovascular system resulting in different types of shock states, depending on the underlying pathophysiology. On one hand, sepsis can cause cardiac depression with (CO) which is the product of heart rate (HR) and stroke volume (SV). As blood pressure is the product of CO × (SVR), this low CO state caused by shock triggers a reactive increase in the SVR to maintain an adequate BP, to keep the vital organs well perfused at the expense of non-vital organs such as the skin. This results the extremities becoming cold, hence the name of “cold shock”. This high SVR will lead to increase in afterload with further decrease in CO leading to a narrow pulse pressure Echocardiography is not routinely done in patient with sepsis and septic shock. Echocardiography helps in the early goal-directed therapy protocol that may improve cardiac dysfunction, intravascular volume resuscitation and hypovolemia (3) Echo cardiographic parameters may be used as surrogate marker for predicting outcome in patient with sepsis and septic shock. As an important organ system frequently compromised by sepsis and always affected by septic shock, the cardiovascular system and its dysfunction during sepsis have been studied in clinical and basic research for more than 5 decades. In this study, we aimed to compare Echo derived indices versus cardiometry derived indices in management of septic patients. Our primary outcome will be 30 days mortality among patients with sepsis. Secondary outcome will be the required amount of fluid, vasopressor, inotrope, hospital stay period, ICU stay period, incidence of mechanical ventilation and ventilation stay period amonge patients with sepsis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/06/2019
Actual trial start date
Anticipated date of last follow up 31/01/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group EGDT group after receiving treatment by early goal-directed therapy by IV fluid 4-6 ml/kg as bolus (max 30 ml/kg) administration to target a central venous pressure (CVP) of 8–12 mmHg, vasopressor infusions to target a mean arterial pressure (MAP) > 65 mmHg, and blood transfusions and dobutamine infusions to target a lactate clearance will be < 10%. All the subjects in this group with sepsis will be undergoing evaluation by the assessment consisted of measuring a CVP, MAP andlactate,. When the CVP will be at goal, vasopressors will be administered to target a MAP ≥ 65 mmHg. Once both CVP and MAP will be at goal, and lactate clearance will be < 10%, dobutamine will be initiated at a dose of 5 mcg/kg/min. Dobutamine could be titrated up to a maximum dose of 15 mcg/kg/min. after receiving treatment by early goal-directed therapy by IV fluid 4-6 ml/kg as bolus (max 30 ml/kg) administration to target a central venous pressure (CVP) of 8–12 mmHg, vasopressor infusions to target a mean arterial pressure (MAP) > 65 mmHg, and blood transfusions and dobutamine infusions to target a lactate clearance will be < 10%. All the subjects in this group with sepsis will be undergoing evaluation by the assessment consisted of measuring a CVP, MAP andlactate,. When the CVP will be at goal, vasopressors will be administered to target a MAP ≥ 65 mmHg. Once both CVP and MAP will be at goal, and lactate clearance will be < 10%, dobutamine will be initiated at a dose of 5 mcg/kg/min. Dobutamine could be titrated up to a maximum dose of 15 mcg/kg/min. after receiving treatment by early goal-directed therapy by IV fluid 4-6 ml/kg as bolus (max 30 ml/kg) administration to target a central venous pressure (CVP) of 8–12 mmHg, vasopressor infusions to target a mean arterial pressure (MAP) > 65 mmHg, and blood transfusions and dobutamine infusions to target a lactate clearance will be < 10%. All the subjects in this group with sepsis will be undergoing evaluation by the assessment consisted of measuring a CVP, MAP andlactate,. When the CVP will be at goal, vasopressors will be administered to target a MAP ≥ 65 mmHg. Once both CVP and MAP will be at goal, and lactate clearance will be < 10%, dobutamine will be initiated at a dose of 5 mcg/kg/min. Dobutamine could be titrated up to a maximum dose of 15 mcg/kg/min. 30 Active-Treatment of Control Group
Experimental Group cardiometry group after receiving treatment either by fluid, vasopressor and inotrope, all the subjects with sepsis underwent evaluation by The Electrical cardiometry monitor (ICON cardiotronic, Inc., La Jolla, CA92307; Osyka medical GmbH, Berlin, AND Germany, model C3, serial number 1725303). Patients will be studied in a supine position. For this purpose, four sensors will be applied- first: approximately 5 cm above left base of the neck, second on the left base of neck, third on the lower left thorax at level of xiphoid and the fourth one on the lower left thorax approximately 5 cm below the 3rd electrode at the level of anterior axillary line. will be connected to the sensor cable and the patient data will be fed. The ICON monitor incorporates an algorithm which transforms the ohmic equivalent of mean aortic blood flow acceleration into an equivalent of mean aortic blood flow velocity. after receiving treatment either by fluid, vasopressor and inotrope, all the subjects with sepsis underwent evaluation by The Electrical cardiometry monitor (ICON cardiotronic, Inc., La Jolla, CA92307; Osyka medical GmbH, Berlin, AND Germany, model C3, serial number 1725303). Patients will be studied in a supine position. For this purpose, four sensors will be applied- first: approximately 5 cm above left base of the neck, second on the left base of neck, third on the lower left thorax at level of xiphoid and the fourth one on the lower left thorax approximately 5 cm below the 3rd electrode at the level of anterior axillary line. will be connected to the sensor cable and the patient data will be fed. The ICON monitor incorporates an algorithm which transforms the ohmic equivalent of mean aortic blood flow acceleration into an equivalent of mean aortic blood flow velocity. after receiving treatment either by fluid, vasopressor and inotrope, all the subjects with sepsis underwent evaluation by The Electrical cardiometry monitor (ICON cardiotronic, Inc., La Jolla, CA92307; Osyka medical GmbH, Berlin, AND Germany, model C3, serial number 1725303). Patients will be studied in a supine position. For this purpose, four sensors will be applied- first: approximately 5 cm above left base of the neck, second on the left base of neck, third on the lower left thorax at level of xiphoid and the fourth one on the lower left thorax approximately 5 cm below the 3rd electrode at the level of anterior axillary line. will be connected to the sensor cable and the patient data will be fed. The ICON monitor incorporates an algorithm which transforms the ohmic equivalent of mean aortic blood flow acceleration into an equivalent of mean aortic blood flow velocity. 30
Experimental Group ECHO group after receiving treatment either by fluid, vasopressor and inotrope, all the subjects with sepsis underwent resting transthoracic 2-dimensional echocardiography by echocardiography machine (5-1 MHz multifrequency probe) according to the standard protocol performed with the patient in the semirecumbent position by experienced cardiovascular trained in advanced critical care echocardiography. after receiving treatment either by fluid, vasopressor and inotrope, all the subjects with sepsis underwent resting transthoracic 2-dimensional echocardiography by echocardiography machine (5-1 MHz multifrequency probe) according to the standard protocol performed with the patient in the semirecumbent position by experienced cardiovascular trained in advanced critical care echocardiography. after receiving treatment either by fluid, vasopressor and inotrope, all the subjects with sepsis underwent resting transthoracic 2-dimensional echocardiography by echocardiography machine (5-1 MHz multifrequency probe) according to the standard protocol performed with the patient in the semirecumbent position by experienced cardiovascular trained in advanced critical care echocardiography. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
90 Patients aged ≥ 18 Years, non-pregnant patients and of both the genders admitted to Intensive Care Unit (ICU) who required treatment of sepsis. The taskforce emphasized the use of the Sequential (sepsis-related) Organ Failure Assessment (SOFA) score, and organ dysfunction can be represented by an increase in the SOFA score of 2 points or more. Enrolment of patients should occur within 8 hours of meeting criteria for sepsis. 1. Age < 18 years 2. Known to be with acute coronary syndrome 3. Known to be Major cardiac dysrhythmia 4. Known to be Valvular or congenital heart disease 5. Known to be left systolic dysfunction as cardiomyopathic and another primary lung disease 6. Known to be Hepatic and or renal dysfunction 7. Severe anemia and any other disease which will affect cardiac hemodynamics or cardiac function. 8. Known to be with any cardiac rhythm other than sinus rhythm 9. patients unable to lie supine 10. peripheral vasoconstriction causing obliteration of the plethysmographic signal. 11. Pregnant Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/04/2019 research ethics committee
Ethics Committee Address
Street address City Postal code Country
El Bahr St. Tanta Qism 2, Tanta, Gharbia Governorate, Egypt tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 30 days mortality among patients with sepsis. 30 days mortality among patients with sepsis.
Secondary Outcome the required amount of fluid, vasopressor, inotrope, hospital stay period, ICU stay period, incidence of mechanical ventilation and ventilation stay period among patients with sepsis. the required amount of fluid, vasopressor, inotrope, hospital stay period, ICU stay period, incidence of mechanical ventilation and ventilation stay period among patients with sepsis.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospital 1, algeish st, tanta,algharbia governate, egypt tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
amany faheem 21, algeish st, tanta,algharbia governate, egypt tanta 31511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University El Bahr St. Tanta Qism 2, Tanta, Gharbia Governorate, Egypt tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Elsayed Afandy El Bahr St. Tanta Qism 2, Tanta, Gharbia Governorate, Egypt tanta Egypt
Sarah Ibrahim El Sharkawy El Bahr St. Tanta Qism 2, Tanta, Gharbia Governorate, Egypt tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amany Omara amanyfaheem2011@yahoo.com 0201008372249 El Bahr St. Tanta Qism 2, Tanta, Gharbia Governorate, Egypt
City Postal code Country Position/Affiliation
tanta 31511 Egypt lecture
Role Name Email Phone Street address
Public Enquiries nada omara Dr.nada.emera@gmail.com 0201118342012 El Bahr St. Tanta Qism 2, Tanta, Gharbia Governorate, Egypt
City Postal code Country Position/Affiliation
Tanta Egypt assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries sohair soliman sohairsoliman@hotmail.com 0201283929049 El Bahr St.Tanta Qism 2, Tanta, Gharbia Governorate, Egypt
City Postal code Country Position/Affiliation
Tanta Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes non identified patients data will be available with the principle investigator for 6 months after publication of the paper Study Protocol 6 months from publication of the paper amanyfaheem2011@yahoo.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information