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Completed

NCT Number: NCT01443494

High MAP in Septic Shock With Hypertension

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

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NE

Other

norepinephine

Primary outcomes

  1. Mean Arterial Pressure

    Time frame: 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 outcomes

  1. Perfused Vessel Density

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

High Mean Arterial Pressure Target Improves Microcirculation in Septic Shock Patients With Previous Hypertension

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 29, 2011
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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