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Microcirculation After MAP Increase in Septic Shock Patients With Previous Hypertension

Information source: Federal University of So Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Septic Shock

Intervention: norepinephrine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Federal University of So Paulo

Official(s) and/or principal investigator(s):
Flavia Machado, PhD, Study Chair, Affiliation: Federal University of São Paulo

Overall contact:
Karla Coimbra, MD, Phone: +55 11 5576 4522, Email: karla.tuanny@hotmail.com

Summary

The optimal levels of mean arterial pressure that must be achieved in septic shock are subject of debate. Studies tried to correlate blood pressure increase in patients with septic shock with microcirculation. However, there are few studies that specifically assessed septic shock patients with previous arterial hypertension. The main objective of this study is to evaluate the effect of increased blood pressure level in the microcirculation of these patients and compare them with patients without arterial hypertension.

Clinical Details

Official title: Microcirculation After MAP Increase in Septic Shock Patients With Previous Hypertension

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Microcirculatory flow index (MIF) measured by sidestream darkfield after rising the mean arterial pressure with norepinephrine

Secondary outcome:

Total vascular density (TVD) measured by sidestream darkfield after rising the mean arterial pressure with norepinephrine

Perfused vascular density (PVD) measured by sidestream darkfield after rising the mean arterial pressure with norepinephrine

Proportional perfused vessels (PPV) measured by sidestream darkfield after rising the mean arterial pressure with norepinephrine

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Karla Coimbra, MD, Phone: +55 11 5576 4522, Email: karla.tuanny@hotmail.com

Hospital São Paulo - Universidade Federal de São Paulo, São Paulo 04024-003, Brazil; Recruiting
GR Machado, PhD, Phone: +55 11 5576 4522, Email: frmachado@unifesp.br
Karla TF Coimbra, MD, Phone: +55 11 5576 4522, Email: karla.tuanny@hotmail.com
Additional Information

Related publications:

Xu JY, Ma SQ, Pan C, He HL, Cai SX, Hu SL, Liu AR, Liu L, Huang YZ, Guo FM, Yang Y, Qiu HB. A high mean arterial pressure target is associated with improved microcirculation in septic shock patients with previous hypertension: a prospective open label study. Crit Care. 2015 Mar 30;19:130. doi: 10.1186/s13054-015-0866-0.

Dubin A, Pozo MO, Casabella CA, Pálizas F Jr, Murias G, Moseinco MC, Kanoore Edul VS, Pálizas F, Estenssoro E, Ince C. Increasing arterial blood pressure with norepinephrine does not improve microcirculatory blood flow: a prospective study. Crit Care. 2009;13(3):R92. doi: 10.1186/cc7922. Epub 2009 Jun 17.

Corrêa TD, Vuda M, Takala J, Djafarzadeh S, Silva E, Jakob SM. Increasing mean arterial blood pressure in sepsis: effects on fluid balance, vasopressor load and renal function. Crit Care. 2013 Jan 30;17(1):R21. doi: 10.1186/cc12495.

Leone M, Asfar P, Radermacher P, Vincent JL, Martin C. Optimizing mean arterial pressure in septic shock: a critical reappraisal of the literature. Crit Care. 2015 Mar 10;19:101. doi: 10.1186/s13054-015-0794-z.

Starting date: March 2013
Last updated: August 6, 2015

Page last updated: August 23, 2015

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