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- Essai clinique NCT01443494
High MAP in Septic Shock With Hypertension
High Mean Arterial Pressure Target Improves Microcirculation in Septic Shock Patients With Previous Hypertension
Aperçu de l'étude
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Jiangsu
-
Nanjing, Jiangsu, Chine, 210000
- Zhongda Hospital Southeast University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: NE group
Adjust NE dose to titrate MAP to usual level regardless of fluid responsiveness when after EGDT.
|
norepinephine
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Mean Arterial Pressure
Délai: 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. |
Target MAP stabilization for 30 min
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Perfused Vessel Density
Délai: 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
|
Target MAP stabilization for 30 min
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Haibo Qiu, MD,PhD, Southeast university
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SoutheastUChina2011ZDllKY03.0
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