Microcirculation After MAP Increase in Septic Shock Patients With Previous Hypertension
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02519699|
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock||Drug: norepinephrine||Phase 4|
Hypothesis: After a rise in mean arterial pressure, microcirculation improvement will occur only in the previously hypertensive patients.
Study design: Prospective clinical trial Setting: Intensive care units of the Anesthesiology Department at the Federal University of Sao Paulo and the intensive care unit of Kidney Hospital.
Studied population: Forty patients will be included, being 20 without known history of systemic arterial hypertension and 20 with this diagnosis for at least 2 years and already with clinical or subclinical organ damage.
Inclusion criteria: age over than 18 years old, norepinephrine drug use for at least 12 hours and for less than 72 hours, sedation level equal or deeper than Ramsay 4, blood pressure stable for the last 30 minutes prior to inclusion, central venous catheter in place and signed informed consent.
Exclusion criteria: pregnancy, cirrhosis, systemic sclerosis, and need to maintain mean arterial pressure above 65mmHg for others conditions.
Intervention: noradrenaline dose will be risen to obtain a mean arterial pressure of 85-90 mmHg.
Assessments and outcome: Systemic hemodynamic (central venous oxygen saturation, cardiac output, heart rate, central venous pressure) and sublingual microcirculation variables (microcirculatory flow index, total vascular density, proportion of perfused vessels, perfused vascular density) will be measured before and after the rise in mean arterial pressure. Sidestream darkfield will be used to assess microcirculation. The variation between those variables before and after the intervention will be compared.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Microcirculation After MAP Increase in Septic Shock Patients With Previous Hypertension|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||January 2017|
Noradrenaline continuous infusion IV
Increase in mean arterial pressure using norepinephrine
Other Name: noradrenaline
- Microcirculatory flow index (MIF) measured by sidestream darkfield after rising the mean arterial pressure with norepinephrine [ Time Frame: after 20 min ]MIF will be measured in points varying from 0 to 4
- Total vascular density (TVD) measured by sidestream darkfield after rising the mean arterial pressure with norepinephrine [ Time Frame: after 20 min ]TVD will be measured in mm/mm2
- Perfused vascular density (PVD) measured by sidestream darkfield after rising the mean arterial pressure with norepinephrine [ Time Frame: after 20 min ]PVD will be measured in mm/mm2
- Proportional perfused vessels (PPV) measured by sidestream darkfield after rising the mean arterial pressure with norepinephrine [ Time Frame: after 20 min ]PPV will be measured in percentage
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): NCT02519699
|Hospital São Paulo - Universidade Federal de São Paulo|
|São Paulo, Brazil, 04024-003|
|Study Chair:||Flavia Machado, PhD||Federal University of São Paulo|