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The present study was conducted as a prospective, randomized study to investigate the effects of vasopressin receptor agonists terlipressin and vasopressin on systemic hemodynamics and microcirculation in patients with catecholamine-dependent septic shock.
60 septic shock patients requiring norepinephrine to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation will be enrolled in the study. After an initial hemodynamic resuscitation aimed at achieve a mean arterial pressure between 65 and 75 mmHg and normovolemia, patients will be randomly allocated to be treated with either a) intravenous administration of terlipressin 1 Āµgākg-1āh-1 for 6 hrs, b) intravenous administration of arginine vasopressin 0.04 UIāmin-1 for 6 hrs, c) intravenous administration of terlipressin bolus dose of 0.5 mg (each n = 20). In all groups open label norepinephrine will be additionally administered to maintain a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization and sublingual microvascular network will be obtained just before randomization (baseline) and then after 6 hours in the vasopressin, terlipressin infusion and terlipressin bolus groups.
The sublingual microvascular network will be studied using the sidestream dark field (SDF)imaging. The device will be applied on the lateral side of the tongue, in an area approximately 2-4 cm from the tip of the tongue. Sequences of 10 secs from eight adjacent areas will be recorded on disk using a personal computer. These sequences will be later analyzed by an investigator blinded to the patient's diagnosis and therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| continuous terlipressin | Experimental |
| |
| vasopressin | Experimental |
| |
| terlipressin bolus dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous infusion of terlipressin | Drug | Intravenous continuous infusion of terlipressin 1 Āµgā¢kg-1ā¢h-1 for 6 hrs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI) | over a period of 6 hrs from the time of randomization | |
| Oxygen transport variables | over a period of 6 from the time of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Acid-base homeostasis | over a period of 6 hrs from the time of randomization | |
| Functional capillary density (mm/mm2) (FCD) | over a period of 6 hrs from the time of randomization | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Morelli, MD | University of Rome "La Sapienza", Department of Anesthesiology and Intensive Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement of Anesthesiology and Intensive Care | Rome | I | 00161 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21929764 | Derived | Morelli A, Donati A, Ertmer C, Rehberg S, Kampmeier T, Orecchioni A, Di Russo A, D'Egidio A, Landoni G, Lombrano MR, Botticelli L, Valentini A, Zangrillo A, Pietropaoli P, Westphal M. Effects of vasopressinergic receptor agonists on sublingual microcirculation in norepinephrine-dependent septic shock. Crit Care. 2011;15(5):R217. doi: 10.1186/cc10453. Epub 2011 Sep 19. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001127 | Arginine Vasopressin |
| ID | Term |
|---|---|
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| Arginine vasopressin | Drug | Intravenous continuous infusion of arginine vasopressin 0.04 UIā¢min-1 for 6 hrs |
|
| terlipressin bolus administration | Drug | intravenous terlipressin bolus administration at the dose of 0.5 mg |
|
| De Backer score |
| over a period of 6 hrs from the time of randomization |
| Perfused Vessel Density (PVD) (mm/mm2) | over a period of 6 hrs from the time of randomization |
| Proportion of Perfused vessels (%) (PPV) | over a period of 6 hrs from the time of randomization |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |