High MAP in Septic Shock With Hypertension

Not Applicable

Completed

• Conditions: Septic Shock
• Interventions: Other: NE

• Registration Number: NCT01443494
• Lead Sponsor: Southeast University, China

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-09-29
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2014-02-27
• Results First Submitted QC: 2014-06-13
• Results First Posted: 2014-06-16
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NE group	NE	Adjust NE dose to titrate MAP to usual level regardless of fluid responsiveness when after EGDT.

Primary Outcome Measures

Name	Time	Method
Mean Arterial Pressure	Target MAP stabilization for 30 min	As chronic hypertensive patients were supposed to have undergone more blood pressure measurements in daily life than non-hypertensive ones, the averaged MAP acquired from patients' physical examination records of the last two years was registered and assumed as patients' usual level of MAP and target MAP. If patients' medical records were incomplete, a detailed enquiry about the target MAP to their next kin was performed.; After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.

Secondary Outcome Measures

Name	Time	Method
Perfused Vessel Density	Target MAP stabilization for 30 min	Increasing MAP from 65 mm Hg to target level. The sublingual microcirculation was measured by sidestream dark field, including the parameters of perfused vessel density

Trial Locations

Locations (1)

Zhongda Hospital Southeast University; 🇨🇳 Nanjing, Jiangsu, China