High MAP in Septic Shock With Hypertension

NCT ID: NCT01443494

Last Updated: 2017-07-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Septic Shock

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NE group

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

Group Type EXPERIMENTAL

NE

Intervention Type OTHER

norepinephine

Interventions

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NE

norepinephine

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Jingyuan,Xu

ZhongDa Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haibo Qiu, MD,PhD

Role: STUDY_DIRECTOR

Southeast University

Locations

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Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 15343008 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23363690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23534963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17584921 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10966242 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19384212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19534818 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21936903 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25887027 (View on PubMed)

Other Identifiers

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SoutheastUChina2011ZDllKY03.0

Identifier Type: -

Identifier Source: org_study_id

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