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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004773-13 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
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This is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of vasopressin and methylprednisolone during adult in-hospital cardiac arrest. There will be ten enrolling sites in Denmark. 492 adult patients with in-hospital cardiac arrest receiving at least one dose of adrenaline will be enrolled. The primary outcome is return of spontaneous circulation and key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vasopressin and methylprednisolone | Experimental | The study drugs will consist of 40 mg methylprednisolone (Solu-medrolĀ®, Pfizer) and 20 IU of vasopressin (EmpressinĀ®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU). |
|
| Placebo | Placebo Comparator | The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl ("normal saline") from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasopressin, Arginine | Drug | 20 IE of vasopressin per dose for a maximum of four doses (80 IU) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Return of Spontaneous Circulation | Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes | During the cardiac arrest, an average of 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Survived 30 Days | At 30 days | |
| Number of Participants With a Favorable Neurological Outcome at 30 Days | A favorable neurological outcome will be defined as a cerebral performance category score of 1 or 2. The cerebral performance category score is a 5-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Vasopressor-free Days | Vasopressor-free days will be defined as the number of days within the first 7 days after the cardiac arrest where the patient is not receiving vasopressors and is alive. | 7 days |
| Invasive Ventilation-free Days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars W Andersen, MD, MPH, PhD, DMSc | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | ||||
| Aarhus University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34587236 | Derived | Andersen LW, Isbye D, Kjaergaard J, Kristensen CM, Darling S, Zwisler ST, Fisker S, Schmidt JC, Kirkegaard H, Grejs AM, Rossau JRG, Larsen JM, Rasmussen BS, Riddersholm S, Iversen K, Schultz M, Nielsen JL, Lofgren B, Lauridsen KG, Solling C, Paelestik K, Kjaergaard AG, Due-Rasmussen D, Folke F, Charlot MG, Jepsen RMHG, Wiberg S, Donnino M, Kurth T, Hoybye M, Sindberg B, Holmberg MJ, Granfeldt A. Effect of Vasopressin and Methylprednisolone vs Placebo on Return of Spontaneous Circulation in Patients With In-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2021 Oct 26;326(16):1586-1594. doi: 10.1001/jama.2021.16628. | |
| 34223347 |
| Label | URL |
|---|---|
| Trial website | View source |
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Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing. Procedures, including re-coding of key variables, will be put in place to allow for complete de-identification of the data. Data will be completely anonymized according to Danish law.
All relevant trial-related documents, including the protocol, data dictionary, and the main statistical code, will be shared along with the data. There will be no predetermined end date for the data sharing.
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Data will be available for any research purpose to all interested parties who have approval from an independent review committee and who have a methodological sound proposal as determined by the steering committee of the current trial. Only the methodological qualities and not the purpose or objective of the proposal will be considered. Interested parties will be able to request the data by contacting the principal investigator. Authorship of publications emerging from the shared data will follow standard authorship guidelines from the International Committee of Medical Journal Editors and might or might not include authors from the steering committee depending on the nature of their involvement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vasopressin and Methylprednisolone | The study drugs will consist of 40 mg methylprednisolone (Solu-medrolĀ®, Pfizer) and 20 IU of vasopressin (EmpressinĀ®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU). Vasopressin, Arginine: 20 IE of vasopressin per dose for a maximum of four doses (80 IU) Methylprednisolone: 40 mg methylprednisolone once |
| FG001 | Placebo | The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl ("normal saline") from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl. NaCl: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vasopressin and Methylprednisolone | The study drugs will consist of 40 mg methylprednisolone (Solu-medrolĀ®, Pfizer) and 20 IU of vasopressin (EmpressinĀ®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU). Vasopressin, Arginine: 20 IE of vasopressin per dose for a maximum of four doses (80 IU) Methylprednisolone: 40 mg methylprednisolone once |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Return of Spontaneous Circulation | Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes | Posted | Number | participants | During the cardiac arrest, an average of 20 minutes |
|
Through hospital admission up to 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vasopressin and Methylprednisolone | The study drugs will consist of 40 mg methylprednisolone (Solu-medrolĀ®, Pfizer) and 20 IU of vasopressin (EmpressinĀ®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU). Vasopressin, Arginine: 20 IE of vasopressin per dose for a maximum of four doses (80 IU) Methylprednisolone: 40 mg methylprednisolone once |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lars W. Andersen | Aarhus University | +4551781511 | lwandersen@clin.au.dk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2020 | Oct 16, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001127 | Arginine Vasopressin |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| Methylprednisolone | Drug | 40 mg methylprednisolone once |
|
| NaCl | Drug | Placebo |
|
| At 30 days |
Invasive ventilation-free days will be defined as the number of days within the first 7 days after the cardiac arrest where the patient is not receiving invasive ventilation and is alive.
| 7 days |
| Sequential Organ Failure Assessment (SOFA) Score at 24, 48 and 72 Hours | The SOFA score is a validated and widely used measure of organ failure assessing the respiratory, nervous, cardiovascular, hepatic, coagulation, and renal systems. We will assess both the cardiovascular sub score as well as the overall SOFA score. | 24, 48 and 72 hours |
| Hospital Disposition | Hospital disposition (e.g. home, rehabilitation, nursing home, hospice) will be defined at the time of discharge from the initial acute care hospital. | At hospital discharge, up to 1 year |
| Survival | At 90 days, 180 days, and 1 year |
| Favorable Neurological Outcome | A favorable neurological outcome will be defined as a cerebral performance category score of 1 or 2. The cerebral performance category score is a 5-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes. | At 90 days, 180 days, and 1 year |
| Modified Rankin Scale (mRS) | The mRS is a 7-point scale, ranging from 0 (no symptoms) to 6 (dead), assessing the degree of disability and dependence after a neurological injury such as stroke or cardiac arrest. A good outcome will be defined as a mRS of 0 to 3 and a poor outcome as 4 to 6. | At 30 days, 90 days, 180 days, and 1 year |
| Glasgow Outcome Scale Extended (GOSE) | The GOSE is a 8-point scale that is an extension of the Glasgow Outcomes Scale (which is identical to the CPC, only with inverse scores) where the scores 1, 2 and 3 from the CPC score is divided into two. | At 30 days, 90 days, 180 days, and 1 year |
| Health-related Quality of Life (EQ-5D-5L) | The EQ-5D-5L is a well-established measure of health-related quality of life that is quantified as a utility (i.e. a measure of quality of life between 0 and 1). | At 30 days, 90 days, 180 days, and 1 year |
| Aarhus |
| Denmark |
| Copenhagen University Hospital - Rigshospitalet | Copenhagen | Denmark |
| Copenhagen University Hospital - Gentofte | Hellerup | Denmark |
| Copenhagen University Hospital - Herlev | Herlev | Denmark |
| Horsens Regional Hospital | Horsens | Denmark |
| Zealand University Hospital - KĆøge | KĆøge | Denmark |
| Odense University Hospital | Odense | Denmark |
| Randers Regional Hospital | Randers | Denmark |
| Viborg Regional Hospital | Viborg | Denmark |
| Derived |
| Andersen LW, Sindberg B, Holmberg M, Isbye D, Kjaergaard J, Zwisler ST, Darling S, Larsen JM, Rasmussen BS, Lofgren B, Lauridsen KG, Paelestik KB, Solling C, Kjaergaard AG, Due-Rasmussen D, Folke F, Charlot MG, Iversen K, Schultz M, Wiberg S, Jepsen RMHG, Kurth T, Donnino M, Kirkegaard H, Granfeldt A. Vasopressin and methylprednisolone for in-hospital cardiac arrest - Protocol for a randomized, double-blind, placebo-controlled trial. Resusc Plus. 2021 Jan 30;5:100081. doi: 10.1016/j.resplu.2021.100081. eCollection 2021 Mar. |
| BG001 | Placebo | The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl ("normal saline") from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl. NaCl: Placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Placebo |
The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl ("normal saline") from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl. NaCl: Placebo |
|
|
| Secondary | Number of Participants That Survived 30 Days | Posted | Count of Participants | Participants | At 30 days |
|
|
|
| Secondary | Number of Participants With a Favorable Neurological Outcome at 30 Days | A favorable neurological outcome will be defined as a cerebral performance category score of 1 or 2. The cerebral performance category score is a 5-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes. | Posted | Count of Participants | Participants | At 30 days |
|
|
|
| Other Pre-specified | Vasopressor-free Days | Vasopressor-free days will be defined as the number of days within the first 7 days after the cardiac arrest where the patient is not receiving vasopressors and is alive. | Not Posted | 7 days | Participants |
| Other Pre-specified | Invasive Ventilation-free Days | Invasive ventilation-free days will be defined as the number of days within the first 7 days after the cardiac arrest where the patient is not receiving invasive ventilation and is alive. | Not Posted | 7 days | Participants |
| Other Pre-specified | Sequential Organ Failure Assessment (SOFA) Score at 24, 48 and 72 Hours | The SOFA score is a validated and widely used measure of organ failure assessing the respiratory, nervous, cardiovascular, hepatic, coagulation, and renal systems. We will assess both the cardiovascular sub score as well as the overall SOFA score. | Not Posted | 24, 48 and 72 hours | Participants |
| Other Pre-specified | Hospital Disposition | Hospital disposition (e.g. home, rehabilitation, nursing home, hospice) will be defined at the time of discharge from the initial acute care hospital. | Not Posted | At hospital discharge, up to 1 year | Participants |
| Other Pre-specified | Survival | Not Posted | At 90 days, 180 days, and 1 year | Participants |
| Other Pre-specified | Favorable Neurological Outcome | A favorable neurological outcome will be defined as a cerebral performance category score of 1 or 2. The cerebral performance category score is a 5-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes. | Not Posted | At 90 days, 180 days, and 1 year | Participants |
| Other Pre-specified | Modified Rankin Scale (mRS) | The mRS is a 7-point scale, ranging from 0 (no symptoms) to 6 (dead), assessing the degree of disability and dependence after a neurological injury such as stroke or cardiac arrest. A good outcome will be defined as a mRS of 0 to 3 and a poor outcome as 4 to 6. | Not Posted | At 30 days, 90 days, 180 days, and 1 year | Participants |
| Other Pre-specified | Glasgow Outcome Scale Extended (GOSE) | The GOSE is a 8-point scale that is an extension of the Glasgow Outcomes Scale (which is identical to the CPC, only with inverse scores) where the scores 1, 2 and 3 from the CPC score is divided into two. | Not Posted | At 30 days, 90 days, 180 days, and 1 year | Participants |
| Other Pre-specified | Health-related Quality of Life (EQ-5D-5L) | The EQ-5D-5L is a well-established measure of health-related quality of life that is quantified as a utility (i.e. a measure of quality of life between 0 and 1). | Not Posted | At 30 days, 90 days, 180 days, and 1 year | Participants |
| 214 |
| 237 |
| 0 |
| 237 |
| 0 |
| 237 |
| EG001 | Placebo | The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl ("normal saline") from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl. NaCl: Placebo | 233 | 264 | 0 | 264 | 0 | 264 |
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| 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 |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |