Clinical trial NCT01443494: High MAP in Septic Shock With Hypertension
Official title: High Mean Arterial Pressure Target Improves Microcirculation in Septic Shock Patients With Previous Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: septic shock
microcirculation
norepinephrine
fluid
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2011-09-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved sublingual microcirculation.

Detailed description: The effect of mean arterial pressure (MAP) titration to higher level on microcirculation in septic shock patients with previous hypertension remains unknown. Our goal was to assess the effect of MAP titration to patients' usual level on microcirculation in septic shock patients with previous hypertension. We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved sublingual microcirculation.

Eligibility criteria: Inclusion Criteria:

* Patients with septic shock for less than 24 hours
* Fluid resuscitation was performed according to the guideline for treating septic shock to maintain the central venous pressure (CVP) for more than 8 mm Hg and central venous oxygen saturation for more than 70%
* Patients requiring norepinephrine (NE) to maintain a MAP of 65 mm Hg. Septic shock patients with fluid resuscitation after CVP \> 8mmHg and mean blood pressure \> 65 mmHg

Exclusion Criteria:

* Pregnancy
* Age \< 18 years
* Inability to acquire the usual level of MAP
* Refusal of consent by the patient or relative
* Participation in other trials during the last three months
* Hypertensive patients without hypertension treatment

Primary outcomes:
measure: Mean Arterial Pressure
timeFrame: Target MAP stabilization for 30 min
Secondary outcomes:
measure: Perfused Vessel Density
timeFrame: Target MAP stabilization for 30 min
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Haibo Qiu, MD,PhD
role: STUDY_DIRECTOR
References:
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citation: Jhanji S, Stirling S, Patel N, Hinds CJ, Pearse RM. The effect of increasing doses of norepinephrine on tissue oxygenation and microvascular flow in patients with septic shock. Crit Care Med. 2009 Jun;37(6):1961-6. doi: 10.1097/CCM.0b013e3181a00a1c.
citation: Dubin A, Pozo MO, Casabella CA, Palizas F Jr, Murias G, Moseinco MC, Kanoore Edul VS, Palizas 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.
citation: Thooft A, Favory R, Salgado DR, Taccone FS, Donadello K, De Backer D, Creteur J, Vincent JL. Effects of changes in arterial pressure on organ perfusion during septic shock. Crit Care. 2011;15(5):R222. doi: 10.1186/cc10462. Epub 2011 Sep 21.
citation: 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(1):130. doi: 10.1186/s13054-015-0866-0.