Clinical trial NCT02085291: Effect of Different Strategies for Titrating a High MAP on Microcirculation
Official title: The Effect of Fluids and Norepinephrine for Mean Arterial Pressure Titration to Patients' Usual Levels on the Microcirculation of Initial Resuscitated Hypertensive Septic Shock Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Septic Shock
Hypertension
Keywords: septic shock; microcirculation; norepinephrine
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2014-03-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the effect of fluids and norepinephrine for mean arterial pressure titration to patients' usual level on the microcirculation of initial resuscitated hypertensive septic shock patients.

Detailed description: Microcirculatory dysfunction plays an important role in the development of organ failure in patients with septic shock. Numerous studies focus on the effect of mean arterial pressure (MAP) titration on microcirculation, however, by what strategy is better for microcirculation in septic shock patients with previous hypertension is still a matter of debate. The goal of this study was to assess the effect of different strategies for MAP titration to individualized level on microcirculation in hypertensive septic shock patients.

Eligibility criteria: Inclusion Criteria:

1. Hypertensive patients with septic shock for less than 24 hours. Septic shock was defined by the 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference.
2. Initial fluid resuscitation was performed to maintain the central venous pressure (CVP) for more than 8 mm Hg and central venous hemoglobin saturation for more than 70%.
3. Patients were still requiring NE to maintain the MAP of 65 mm Hg.

Exclusion Criteria:

1. had severe untreated or uncontrolled hypertension (systolic blood pressure more than 180 mm Hg or/and diastolic blood pressure more than 110 mm Hg);
2. were younger than 18 years old or pregnant;
3. were unable to acquire the usual level or resting level of blood pressure;
4. refused to participate the trial.

Primary outcomes:
measure: Perfused vessel density
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: Southeastt University
name: Haibo Qiu
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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