NCT01443494

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2 years until next milestone

Results Posted

Study results publicly available

June 16, 2014

Completed
Last Updated

July 6, 2017

Status Verified

June 1, 2017

Enrollment Period

1 year

First QC Date

September 28, 2011

Results QC Date

February 27, 2014

Last Update Submit

June 13, 2017

Conditions

Septic Shock

Keywords

septic shockmicrocirculationnorepinephrinefluid

Outcome Measures

Primary Outcomes (1)

  • Mean Arterial Pressure

    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.

    Target MAP stabilization for 30 min

Secondary Outcomes (1)

  • Perfused Vessel Density

    Target MAP stabilization for 30 min

Study Arms (1)

NE group

EXPERIMENTAL

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

Other: NE

Interventions

NEOTHER

norepinephine

NE group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210000, China

Location

Related Publications (9)

  • Sakr Y, Dubois MJ, De Backer D, Creteur J, Vincent JL. Persistent microcirculatory alterations are associated with organ failure and death in patients with septic shock. Crit Care Med. 2004 Sep;32(9):1825-31. doi: 10.1097/01.ccm.0000138558.16257.3f.

    PMID: 15343008BACKGROUND

  • Correa TD, Vuda M, Takala J, Djafarzadeh S, Silva E, Jakob SM. Increasing mean arterial blood pressure in sepsis: effects on fluid balance, vasopressor load and renal function. Crit Care. 2013 Jan 30;17(1):R21. doi: 10.1186/cc12495.

    PMID: 23363690BACKGROUND

  • Beloncle F, Lerolle N, Radermacher P, Asfar P. Target blood pressure in sepsis: between a rock and a hard place. Crit Care. 2013 Mar 26;17(2):126. doi: 10.1186/cc12543.

    PMID: 23534963BACKGROUND

  • Sevransky JE, Nour S, Susla GM, Needham DM, Hollenberg S, Pronovost P. Hemodynamic goals in randomized clinical trials in patients with sepsis: a systematic review of the literature. Crit Care. 2007;11(3):R67. doi: 10.1186/cc5948.

    PMID: 17584921BACKGROUND

  • LeDoux D, Astiz ME, Carpati CM, Rackow EC. Effects of perfusion pressure on tissue perfusion in septic shock. Crit Care Med. 2000 Aug;28(8):2729-32. doi: 10.1097/00003246-200008000-00007.

    PMID: 10966242BACKGROUND

  • Jhanji S, Stirling S, Patel N, Hinds CJ, Pearse RM. The effect of increasing doses of norepinephrine on tissue oxygenation and microvascular flow in patients with septic shock. Crit Care Med. 2009 Jun;37(6):1961-6. doi: 10.1097/CCM.0b013e3181a00a1c.

    PMID: 19384212BACKGROUND

  • Dubin A, Pozo MO, Casabella CA, Palizas F Jr, Murias G, Moseinco MC, Kanoore Edul VS, Palizas F, Estenssoro E, Ince C. Increasing arterial blood pressure with norepinephrine does not improve microcirculatory blood flow: a prospective study. Crit Care. 2009;13(3):R92. doi: 10.1186/cc7922. Epub 2009 Jun 17.

    PMID: 19534818BACKGROUND

  • Thooft A, Favory R, Salgado DR, Taccone FS, Donadello K, De Backer D, Creteur J, Vincent JL. Effects of changes in arterial pressure on organ perfusion during septic shock. Crit Care. 2011;15(5):R222. doi: 10.1186/cc10462. Epub 2011 Sep 21.

    PMID: 21936903BACKGROUND

  • 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.

    PMID: 25887027DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Limitations and Caveats

Firstly, cardiac output was monitored by NICOM system to minimize the invasive operation. Secondly, the number of patients enrolled in the study was relatively small. Next, immediate changes of the increase in MAP were investigated.

Results Point of Contact

Title
Jingyuan Xu
Organization
Intensive Care Unit, Zhongda Hospital, Southeast University
xujingyuanmail@163.com
86-025-83262550

Study Officials

  • Haibo Qiu, MD,PhD

    Southeast University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ZhongDa Hospital

Study Record Dates

First Submitted

September 28, 2011

First Posted

September 29, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 6, 2017

Results First Posted

June 16, 2014

Record last verified: 2017-06

Locations

CN(1)