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Futility by interim analysis
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The purpose of this study is to evaluate the incidence of hypotension based on the discontinuation order of norepinephrine and vasopressin in patients receiving concomitant norepinephrine and vasopressin infusions for the treatment of septic shock.
There are little data regarding the discontinuation of vasopressors in patients with septic shock. Therefore, the investigators intend to evaluate the incidence of hypotension based on the discontinuation order of norepinephrine and vasopressin in patients receiving concomitant norepinephrine and vasopressin infusions for the treatment of septic shock.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vasopressin | Active Comparator | Vasopressin will be reduced first (0.01 U/hour) |
|
| Norepinephrine | Active Comparator | Norepinephrine: Norepinephrine will be reduced first (0.1 microgram/kg/hour) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasopressin | Drug | Vasopressin will be reduced first (0.01 U/hour) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypotension | Hypotension is defined as mean arterial pressure is less than 65mmHg | One hour after dose reduction of vasopressors |
| Measure | Description | Time Frame |
|---|---|---|
| Time of hypotension | Time interval (min) from time of dose reduction of vasopressors to time to development of hypotension | One hour after dose reduction of vasopressors |
| Vasopressor free day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| kyeongman Jeon, M.D., Ph.D. | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29784057 | Derived | Jeon K, Song JU, Chung CR, Yang JH, Suh GY. Incidence of hypotension according to the discontinuation order of vasopressors in the management of septic shock: a prospective randomized trial (DOVSS). Crit Care. 2018 May 21;22(1):131. doi: 10.1186/s13054-018-2034-9. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D003919 | Diabetes Insipidus |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D014667 | Vasopressins |
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Norepinephrine |
| Drug |
Norepinephrine will be reduced first (0.1 microgram/kg/hour) |
|
| 28 days after dose reduction of vasopressors |
| 28-day mortality | All cause mortality within 28 days after hospitalization | 28 days |
| ICU mortality | All cause mortlity during ICU admission | 3 months |
| In-hospital mortality | All cause mortality during hospitalization | 3 months |
| D010335 |
| Pathologic Processes |
| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| 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 |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |