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Effect of Different Strategies for Titrating a High MAP on Microcirculation

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ClinicalTrials.gov Identifier: NCT02085291
Recruitment Status : Completed
First Posted : March 12, 2014
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Jingyuan,Xu, Southeast University, China

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.

Condition or disease Intervention/treatment Phase
Septic Shock Hypertension Drug: Norepinephrine Drug: Crystalloid Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : March 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Resp-FL
Patients received 500 ml crystalloid for fluid challenge within 20 minutes, then a PLR test was performed to predict fluid responsiveness. If the patient was fluid responsive, more 500 ml crystalloids were given until fluid nonresponsive. If the MAP still not achieved the target value, NE was increased to achieve the target one. The target MAP was maintain MAP within 10% of the reference value.
Drug: Crystalloid
Patients received 500 ml crystalloid for fluid challenge within 20 minutes, then a PLR test was performed to predict fluid responsiveness. If the patient was fluid responsive, more 500 ml crystalloids were given until fluid nonresponsive. If the MAP still not achieved the target value, NE was increased to achieve the target one.
Other Name: Fluid group

Experimental: Resp-NE
In Resp-NE group, norepinephrine was increased to enhance MAP within 10% of the reference value.
Drug: Norepinephrine
Norepinephrine infusion to titrate MAP to usual level
Other Name: NE group

Experimental: Nonresp-NE
In Nonresp-NE group, norepinephrine was increased to enhance MAP within 10% of the reference value.
Drug: Norepinephrine
Norepinephrine infusion to titrate MAP to usual level
Other Name: NE group




Primary Outcome Measures :
  1. Perfused vessel density [ Time Frame: 20 minutes ]
    Perfused vessel density of small vessels



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085291


Locations
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China, Jiangsu
Nanjing Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Southeast University, China
Investigators
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Principal Investigator: Haibo Qiu Southeastt University

Publications of Results:

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Responsible Party: Jingyuan,Xu, Zhongda Hospital, Southeast University, China
ClinicalTrials.gov Identifier: NCT02085291     History of Changes
Other Study ID Numbers: 2014ZDll.2
Targeting microcirculation ( Other Identifier: Zhongda Hospital )
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jingyuan,Xu, Southeast University, China:
septic shock; microcirculation; norepinephrine
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents