HypotensionPhase 3NCT03215797
Phenylephrine or Norepinephrine for a Better Hemodynamic Stability
A Phase 3 study testing phenylephrine and Norepinephrine in people with Hypotension and Fluid Therapy, run by The Second Affiliated Hospital of Dalian Medical University.
Trial summary
A prospective, double-blinded study. The present study consisted in applying Stroke volume variation fluid guided therapy to old patients (65 years old) undergoing radical resection of colon surgery. Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotension, Fluid Therapy
- What is being tested?
- phenylephrine and Norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Operation time should be equal or greater than 2h,
- Patients older than 65 years old,
- ASA Ⅱ or Ⅲ.
Who cannot join
- Clear arrhythmia,
- Need to apply PEEP,
- Peripheral vascular disease and arterial catheter contraindications.
About this study
Official title: Comparison of the Effects of Norepinephrine and Phenylephrine on Tissue Oxygenation and Hemodynamic Stability During an SVV Fluid Guided Therapy in Elderly Undergoing Radical Resection of Colon Cancer Surgery
A prospective, double-blinded study. The present study consisted in applying Stroke volume variation fluid guided therapy to old patients (65 years old) undergoing radical resection of colon surgery. The aim of this study is to compare the effects of norepinephrine and phenylephrine in treating perioperative hypotension, and to find the safest and most effective vasopressor for elderly.
Read the detailed description
Fluid management has a great influence on patient's morbidity, mortality and on the overall outcome.Goal directed therapy was proved by multiple studies to be a goal therapy in maintaining a stable hemodynamic state. Nevertheless, as the population worldwide is aging, elderly presenting for surgery are also increasing. This population is known for the multiple comorbidities and physiological changes which makes them prone to dehydration and hypotension. That's when we are going to use either Norepinephrine in one group or Phenylephrine in the other and compare the effects of both vasopressors.
Parameters we are going to use are: Hemodynamic (HR, MAP, CO, CI, SVV, SV); Tissue Oxygenation and perfusion (DO2, VO2, ERO2, CRT, Lactate, blood gas); Urine output.
- Conditions
- Hypotension, Fluid Therapy
- Being tested
- phenylephrine, Norepinephrine
- Keywords
- svv, norepinephrine, phenylephrine, elderly
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenylephrineDrug
Also called α1-adrenergic receptor agonist, vasopressor
phenylephrine 100ug/ml IV infusion at a rate of 5ml/h in case of hypotension.
NorepinephrineDrug
Also called noradrenaline, catecholamine
Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of hypotension
| Study group | Role | What they receive |
|---|---|---|
| phenylephrine and norepinephrine | Active comparator | Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of perioperative hypotension. Receives: Drug: phenylephrine; Drug: Norepinephrine |
| Norepinephrine and phenylephrine | Other | Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion in postoperative time in case of hypotension Receives: Drug: phenylephrine; Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the tissue oxygenation
it means the tissue oxygen delivery and consumption
Measured: from the beginning of surgery to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study startSep 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215797
- Sponsor's protocol ID
- Ph Vs N in SVV GDT
- Status last verified
- Apr 2017
- First submitted
- 9 Apr 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Norepinephrine and Phenylephrine on Tissue Oxygenation and Hemodynamic Stability During an SVV Fluid Guided Therapy in Elderly Undergoing Radical Resection of Colon Cancer Surgery
- ClinicalTrials.gov ID
- NCT03215797
- Acronym / sponsor ID
- Ph Vs N in SVV GDT
- Conditions
- Hypotension, Fluid Therapy
- Keywords
- svv, norepinephrine, phenylephrine, elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, double-blinded study. The present study consisted in applying Stroke volume variation fluid guided therapy to old patients (65 years old) undergoing radical resection of colon surgery. The aim of this study is to compare the effects of norepinephrine and phenylephrine in treating perioperative hypotension, and to find the safest and most effective vasopressor for elderly.
Detailed description
Fluid management has a great influence on patient's morbidity, mortality and on the overall outcome.Goal directed therapy was proved by multiple studies to be a goal therapy in maintaining a stable hemodynamic state. Nevertheless, as the population worldwide is aging, elderly presenting for surgery are also increasing. This population is known for the multiple comorbidities and physiological changes which makes them prone to dehydration and hypotension. That's when we are going to use either Norepinephrine in one group or Phenylephrine in the other and compare the effects of both vasopressors.
Parameters we are going to use are: Hemodynamic (HR, MAP, CO, CI, SVV, SV); Tissue Oxygenation and perfusion (DO2, VO2, ERO2, CRT, Lactate, blood gas); Urine output.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phenylephrine and norepinephrine | Active comparator | Drug: phenylephrine, Drug: NorepinephrinePhenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of perioperative hypotension. |
| Norepinephrine and phenylephrine | Other | Drug: phenylephrine, Drug: NorepinephrinePhenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion in postoperative time in case of hypotension |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Operation time should be equal or greater than 2h,
- Patients older than 65 years old,
- ASA Ⅱ or Ⅲ.
Key exclusion criteria (3 listed)
- Clear arrhythmia,
- Need to apply PEEP,
- Peripheral vascular disease and arterial catheter contraindications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phenylephrineAlso: α1-adrenergic receptor agonist, vasopressorphenylephrine 100ug/ml IV infusion at a rate of 5ml/h in case of hypotension. | Drug | Norepinephrine and phenylephrine, phenylephrine and norepinephrine |
| NorepinephrineAlso: noradrenaline, catecholamineNorepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of hypotension | Drug | Norepinephrine and phenylephrine, phenylephrine and norepinephrine |
Primary outcome
the tissue oxygenation
Time frame: from the beginning of surgery to the end of surgery
it means the tissue oxygen delivery and consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing phenylephrine and Norepinephrine in people with Hypotension and Fluid Therapy, run by The Second Affiliated Hospital of Dalian Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the tissue oxygenation (time frame: from the beginning of surgery to the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.