High MAP in Septic Shock With Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jingyuan,Xu, Southeast University, China
ClinicalTrials.gov Identifier:
NCT01443494
First received: September 28, 2011
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Septic Shock
Other: NE
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Mean Arterial Pressure Target Improves Microcirculation in Septic Shock Patients With Previous Hypertension

Resource links provided by NLM:


Further study details as provided by Southeast University, China:

Primary Outcome Measures:
  • Mean Arterial Pressure [ Time Frame: Target MAP stabilization for 30 min ] [ Designated as safety issue: Yes ]

    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:
  • Perfused Vessel Density [ Time Frame: Target MAP stabilization for 30 min ] [ Designated as safety issue: Yes ]
    Increasing MAP from 65 mm Hg to target level. The sublingual microcirculation was measured by SDF, including the parameters of perfused vessel density


Enrollment: 19
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NE group
Adjust NE dose to titrate MAP to usual level regardless of fluid responsiveness when after EGDT.
Other: NE
norepinephine

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01443494

Locations
China, Jiangsu
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Southeast University, China
Investigators
Study Director: Haibo Qiu, MD,PhD Southeast University
  More Information

Publications:

Responsible Party: Jingyuan,Xu, ZhongDa Hospital, Southeast University, China
ClinicalTrials.gov Identifier: NCT01443494     History of Changes
Other Study ID Numbers: SoutheastUChina2011ZDllKY03.0
Study First Received: September 28, 2011
Results First Received: February 27, 2014
Last Updated: June 13, 2014
Health Authority: China: Ethics Committee

Keywords provided by Southeast University, China:
septic shock
microcirculation
norepinephrine
fluid

Additional relevant MeSH terms:
Hypertension
Shock
Shock, Septic
Cardiovascular Diseases
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014