AnesthesiaPhase 4VEGA-2NCT06802224
The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery
A Phase 4 study testing Norepinephrine and Phenylephrine in people with Anesthesia and Surgery With General Anesthesia, run by University of California, San Francisco at 10 sites in 2 countries.
Trial summary
Low blood pressure, also known as hypotension, is very common during major surgery under general anesthesia. Prolonged or severe hypotension can lead to complications such as kidney injury after surgery that slow down patient recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Surgery With General Anesthesia, Noncardiac Surgery
- What is being tested?
- Norepinephrine and Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,000 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 1 Apr 2025to Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Surgery under general anesthesia with a surgery duration of 2 hours or more
- Received intravenous vasopressors during surgery
Who cannot join
- Cardiac surgery
- Extra-corporeal membrane oxygenation
- Organ transplantation
- Obstetric procedures
- Procedures on the kidney
- Outpatient procedures
Show all 12Show fewer
- Already receiving NE or PE or inotropes before induction of anesthesia (at the time of anesthesia start)
- American Society of Anesthesiologists physical status classification 5 or 6
- Patient for whom a local protocol recommends a specific first line vasopressor
- Most recent documented estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73m^2 or preoperative renal replacement therapy within 60 days before surgery
- Patients who do not have a preoperative creatinine value within 60 days before surgery
- Alive patients who do not have a postoperative creatinine value
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
United States9 sites, 9 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Allison Janda, MD, 734-936-4000, ajanda@med.umich.edu
Rebecca Pantis, repantis@med.umich.edu
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Bhiken Naik, MD, 434-924-2547, bin4n@uvahealth.org
Meghana Ilendula, MI9K@uvahealth.org
- Recruiting
University of Maryland
College Park, Maryland, 20742
Megan Anders, MD, 410-328-4213, manders@som.umaryland.edu
LaToya Stubbs, lstubbs@som.umaryland.edu
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Siddharth Dave, MD, 214-645-8300, Siddharth.Dave@UTSouthwestern.edu
Emily Melikman, Emily.Melikman@UTSouthwestern.edu
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Mousab M Eteer, MD, 989-839-3000, METEER1@hfhs.org
Katherine A Nowak, PhD, KNowak2@hfhs.org
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Michael Manning, MD, 859-619-4712, michael.manning@duke.edu
Amy Patrylick, amy.patrylick@duke.edu
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Michael P Bokoch, MD PhD, 415-476-8389, michael.bokoch@ucsf.edu
Elisia Leung, BA, Elisia.Leung@ucsf.edu
- Recruiting
University of Washington
Seattle, Washington, 98195
Karen B Domino, MD, kdomino@uw.edu
Karen B Domino, MD
- Recruiting
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27101
Ashish Khanna, MD, 336-716-4498, akhanna@wakehealth.edu
Lynnette Harris, lcharris@wakehealth.edu
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Tariq Esmail, MD, 416-603-5118, Tariq.Esmail@uhn.ca
Tariq Esmail, MD
About this study
Official title: Norepinephrine vs Phenylephrine as the First-line Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-cardiac Surgery
Low blood pressure, also known as hypotension, is very common during major surgery under general anesthesia. Prolonged or severe hypotension can lead to complications such as kidney injury after surgery that slow down patient recovery. Anesthesiologists commonly administer medications called vasopressors to treat low blood pressure during surgery. These medications help raise the blood pressure back up to a safe range. Two vasopressor medications are commonly used for this purpose: norepinephrine and phenylephrine. Each of these medications has slightly different effects on the heart and blood vessels (cardiovascular system). It remains unknown which of these standard medications is better for treating low blood pressure during surgery. The goal of this clinical trial is to determine which of these two medications is better at preventing injury to the kidneys after major noncardiac surgery as well as other complications such as heart problems. Major surgeries are defined as those lasting at least two hours under general anesthesia. This trial will randomize about ten centers in North America to use either norepinephrine or phenylephrine as the primary medication to treat low blood pressure in adults undergoing major noncardiac surgery. Each hospital will prioritize one of the drugs each month, and the assigned drug will rotate each month at each hospital. No further participant involvement will be required as de-identified data are collected as part of standard medical care.
Read the detailed description
VEGA-2 is an open-label, pragmatic, multiple periods, cluster-randomized, crossover trial across hospitals from MPOG. Hospital centers will be assigned to use either phenylephrine (PE) or norepinephrine (NE) for the first-line intravenous vasopressor in the operating room for the treatment of intraoperative hypotension. Centers will be randomly assigned to use PE during even-numbered months and NE during odd-numbered months, or vice versa. Data will be collected from routine clinical care and automatically extracted from the electronic health record. No additional lab tests or procedures will be required for the study. Only the randomization (of each hospital to the sequence of interventions) will be different from usual care.
The intervention is the first line vasopressor used for both infusion and bolus dosing, either PE or NE . Anesthesia providers will use the concentration that their respective center already uses in line with local anesthesia and pharmacy standard operating procedures. Anesthesiologists will provide standard of care during the intraoperative period. They will evaluate the need for vasopressors based on hemodynamic assessment and the arterial pressure goals during the procedure. Anesthesia providers will be encouraged to maintain mean arterial pressure above 65 mmHg or within 20% from baseline, but the arterial pressure targets can be adjusted on an individual basis, for instance during pre-surgical time-out, or based on individual assessment. Doses of bolus or continuous infusion of vasopressors will be adjusted to reach these goals on an individual basis. Of note, the anesthesia provider could use the alternative vasopressor if they consider the benefit of one drug being higher. A second line vasopressor will be allowed. The choice of the first line vasopressors will be determined by the randomization block.
- Conditions
- Anesthesia, Surgery With General Anesthesia, Noncardiac Surgery, Hypotension During Surgery, Acute Kidney Injury (AKI), Myocardial Injury After Noncardiac Surgery (MINS)
- Being tested
- Norepinephrine, Phenylephrine
- Keywords
- Norepinephrine, Phenylephrine, Major adverse kidney events, Pragmatic, Cluster randomized, Crossover
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Intravenous Norepinephrine for both infusion and bolus dosing
PhenylephrineDrug
Intravenous Phenylephrine for both infusion and bolus dosing
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine | Active comparator | Norepinephrine as the first-line intraoperative vasopressor during general anesthesia. Receives: Drug: Norepinephrine |
| Phenylephrine | Active comparator | Phenylephrine as the first-line intraoperative vasopressor during general anesthesia Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury (AKI)
AKI will be defined by the change of serum creatinine based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Measured: 7 days
Secondary outcomes (1)
Major Adverse Kidney Events (MAKE)
The composite of severe AKI (i.e. stage 2 or 3 AKI based on the KDIGO creatinine-based definition), absence of renal recovery, and/or death.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Apr 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a multicenter, multiple periods, cluster-randomized, crossover trial design in 10 to 12 sites of the Multicenter Perioperative Outcomes Group (MPOG). The randomization at each site will alternate on a monthly basis between the norepinephrine arm and phenylephrine arm. Each cluster will be a different medical center in a different health system in North America. There will be a 2 month run-in at each site, followed by 12 crossover periods with data collection (6 months randomized to PE, 6 months randomized to NE). This cluster randomization aligns with current clinical practice and is therefore more feasible than an individualized randomization. It also enrolls a diverse population representative of the population being treated in the participating centers. This cluster-randomized crossover design increases the power and the ability to show a realistic difference between the two groups through enrollment of a very large number of patients.
- Masking
- None (open label)
- Enrolment
- 18,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan, Henry Ford Health System, University of Washington, University of Texas Southwestern Medical Center, Wake Forest University Health Sciences, University of Virginia, University of Maryland, Duke University, University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Sachin Kheterpal, MD MBA, Principal investigator, University of MichiganMatthieu Legrand, MD PhD, Principal investigator, University of California, San FranciscoAllison Janda, MD, Study director, University of MichiganMichael P Bokoch, MD PhD, Study director, University of California, San FranciscoDouglas Colquhoun, MB ChB, MSc, MPH, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802224
- Sponsor's protocol ID
- 23-39683
- Other IDs
- R01DK139484
- Acronym
- VEGA-2
- Status last verified
- May 2026
- First submitted
- 28 Jan 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiu C, Fong N, Lazzareschi D, Mavrothalassitis O, Kothari R, Chen LL, Pirracchio R, Kheterpal S, Domino KB, Mathis M, Legrand M. Fluids, vasopressors, and acute kidney injury after major abdominal surgery between 2015 and 2019: a multicentre retrospective analysis. Br J Anaesth. 2022 Sep;129(3):317-326. doi: 10.1016/j.bja.2022.05.002. Epub 2022 Jun 8.
PubMed 35688657Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.
PubMed 28973220Pancaro C, Shah N, Pasma W, Saager L, Cassidy R, van Klei W, Kooij F, Vittali D, Hollmann MW, Kheterpal S, Lirk P. Risk of Major Complications After Perioperative Norepinephrine Infusion Through Peripheral Intravenous Lines in a Multicenter Study. Anesth Analg. 2020 Oct;131(4):1060-1065. doi: 10.1213/ANE.0000000000004445.
PubMed 32925324Prowle JR, Forni LG, Bell M, Chew MS, Edwards M, Grams ME, Grocott MPW, Liu KD, McIlroy D, Murray PT, Ostermann M, Zarbock A, Bagshaw SM, Bartz R, Bell S, Bihorac A, Gan TJ, Hobson CE, Joannidis M, Koyner JL, Levett DZH, Mehta RL, Miller TE, Mythen MG, Nadim MK, Pearse RM, Rimmele T, Ronco C, Shaw AD, Kellum JA. Postoperative acute kidney injury in adult non-cardiac surgery: joint consensus report of the Acute Disease Quality Initiative and PeriOperative Quality Initiative. Nat Rev Nephrol. 2021 Sep;17(9):605-618. doi: 10.1038/s41581-021-00418-2. Epub 2021 May 11.
PubMed 33976395Mets B. Should Norepinephrine, Rather than Phenylephrine, Be Considered the Primary Vasopressor in Anesthetic Practice? Anesth Analg. 2016 May;122(5):1707-14. doi: 10.1213/ANE.0000000000001239. No abstract available.
PubMed 27101504Legrand M, Zarbock A. Ten tips to optimize vasopressors use in the critically ill patient with hypotension. Intensive Care Med. 2022 Jun;48(6):736-739. doi: 10.1007/s00134-022-06708-y. Epub 2022 May 3. No abstract available.
PubMed 35504977Mathis MR, Naik BI, Freundlich RE, Shanks AM, Heung M, Kim M, Burns ML, Colquhoun DA, Rangrass G, Janda A, Engoren MC, Saager L, Tremper KK, Kheterpal S, Aziz MF, Coffman T, Durieux ME, Levy WJ, Schonberger RB, Soto R, Wilczak J, Berman MF, Berris J, Biggs DA, Coles P, Craft RM, Cummings KC, Ellis TA 2nd, Fleishut PM, Helsten DL, Jameson LC, van Klei WA, Kooij F, LaGorio J, Lins S, Miller SA, Molina S, Nair B, Paganelli WC, Peterson W, Tom S, Wanderer JP, Wedeven C; Multicenter Perioperative Outcomes Group Investigators. Preoperative Risk and the Association between Hypotension and Postoperative Acute Kidney Injury. Anesthesiology. 2020 Mar;132(3):461-475. doi: 10.1097/ALN.0000000000003063.
PubMed 31794513Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.
PubMed 27792044Legrand M, Kothari R, Fong N, Palaniappa N, Boldt D, Chen LL, Kurien P, Gabel E, Sturgess-DaPrato J, Harhay MO, Pirracchio R, Bokoch MP; VEGA-1 trial investigators. Norepinephrine versus phenylephrine for treating hypotension during general anaesthesia in adult patients undergoing major noncardiac surgery: a multicentre, open-label, cluster-randomised, crossover, feasibility, and pilot trial. Br J Anaesth. 2023 May;130(5):519-527. doi: 10.1016/j.bja.2023.02.004. Epub 2023 Mar 14.
PubMed 36925330Joosten A, Chew MS, Futier E, Harrois A, Jacquet-Lagreze M, Legrand M, Messina A, Myles PS, Saugel B, Sessler DI, Veelo DP, Fellahi JL. Intraoperative blood pressure management in noncardiac surgery: a narrative review based on current evidence. Intensive Care Med. 2026 Mar;52(3):500-511. doi: 10.1007/s00134-026-08326-4. Epub 2026 Feb 17.
PubMed 41701325
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine vs Phenylephrine as the First-line Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT06802224
- Acronym / sponsor ID
- VEGA-2 / 23-39683
- Conditions
- Anesthesia, Surgery With General Anesthesia, Noncardiac Surgery, Hypotension During Surgery, Acute Kidney Injury (AKI), Myocardial Injury After Noncardiac Surgery (MINS)
- Keywords
- Norepinephrine, Phenylephrine, Major adverse kidney events, Pragmatic, Cluster randomized, Crossover
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan, Henry Ford Health System, University of Washington, University of Texas Southwestern Medical Center, Wake Forest University Health Sciences, University of Virginia, University of Maryland, Duke University, University Health Network, Toronto
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 31 Jan 2025 (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.
Low blood pressure, also known as hypotension, is very common during major surgery under general anesthesia. Prolonged or severe hypotension can lead to complications such as kidney injury after surgery that slow down patient recovery. Anesthesiologists commonly administer medications called vasopressors to treat low blood pressure during surgery. These medications help raise the blood pressure back up to a safe range. Two vasopressor medications are commonly used for this purpose: norepinephrine and phenylephrine. Each of these medications has slightly different effects on the heart and blood vessels (cardiovascular system). It remains unknown which of these standard medications is better for treating low blood pressure during surgery. The goal of this clinical trial is to determine which of these two medications is better at preventing injury to the kidneys after major noncardiac surgery as well as other complications such as heart problems. Major surgeries are defined as those lasting at least two hours under general anesthesia. This trial will randomize about ten centers in North America to use either norepinephrine or phenylephrine as the primary medication to treat low blood pressure in adults undergoing major noncardiac surgery. Each hospital will prioritize one of the drugs each month, and the assigned drug will rotate each month at each hospital. No further participant involvement will be required as de-identified data are collected as part of standard medical care.
Detailed description
VEGA-2 is an open-label, pragmatic, multiple periods, cluster-randomized, crossover trial across hospitals from MPOG. Hospital centers will be assigned to use either phenylephrine (PE) or norepinephrine (NE) for the first-line intravenous vasopressor in the operating room for the treatment of intraoperative hypotension. Centers will be randomly assigned to use PE during even-numbered months and NE during odd-numbered months, or vice versa. Data will be collected from routine clinical care and automatically extracted from the electronic health record. No additional lab tests or procedures will be required for the study. Only the randomization (of each hospital to the sequence of interventions) will be different from usual care.
The intervention is the first line vasopressor used for both infusion and bolus dosing, either PE or NE . Anesthesia providers will use the concentration that their respective center already uses in line with local anesthesia and pharmacy standard operating procedures. Anesthesiologists will provide standard of care during the intraoperative period. They will evaluate the need for vasopressors based on hemodynamic assessment and the arterial pressure goals during the procedure. Anesthesia providers will be encouraged to maintain mean arterial pressure above 65 mmHg or within 20% from baseline, but the arterial pressure targets can be adjusted on an individual basis, for instance during pre-surgical time-out, or based on individual assessment. Doses of bolus or continuous infusion of vasopressors will be adjusted to reach these goals on an individual basis. Of note, the anesthesia provider could use the alternative vasopressor if they consider the benefit of one drug being higher. A second line vasopressor will be allowed. The choice of the first line vasopressors will be determined by the randomization block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multicenter, multiple periods, cluster-randomized, crossover trial design in 10 to 12 sites of the Multicenter Perioperative Outcomes Group (MPOG). The randomization at each site will alternate on a monthly basis between the norepinephrine arm and phenylephrine arm. Each cluster will be a different medical center in a different health system in North America. There will be a 2 month run-in at each site, followed by 12 crossover periods with data collection (6 months randomized to PE, 6 months randomized to NE). This cluster randomization aligns with current clinical practice and is therefore more feasible than an individualized randomization. It also enrolls a diverse population representative of the population being treated in the participating centers. This cluster-randomized crossover design increases the power and the ability to show a realistic difference between the two groups through enrollment of a very large number of patients.
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine | Active comparator | Drug: NorepinephrineNorepinephrine as the first-line intraoperative vasopressor during general anesthesia. |
| Phenylephrine | Active comparator | Drug: PhenylephrinePhenylephrine as the first-line intraoperative vasopressor during general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Surgery under general anesthesia with a surgery duration of 2 hours or more
- Received intravenous vasopressors during surgery
Key exclusion criteria (12 listed)
- Cardiac surgery
- Extra-corporeal membrane oxygenation
- Organ transplantation
- Obstetric procedures
- Procedures on the kidney
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 |
|---|---|---|
| NorepinephrineIntravenous Norepinephrine for both infusion and bolus dosing | Drug | Norepinephrine |
| PhenylephrineIntravenous Phenylephrine for both infusion and bolus dosing | Drug | Phenylephrine |
Primary outcome
Acute Kidney Injury (AKI)
Time frame: 7 days
AKI will be defined by the change of serum creatinine based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
1 secondary outcome
Major Adverse Kidney Events (MAKE)
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 35688657Chiu C, Fong N, Lazzareschi D, Mavrothalassitis O, Kothari R, Chen LL, Pirracchio R, Kheterpal S, Domino KB, Mathis M, Legrand M. Fluids, vasopressors, and acute kidney injury after major abdominal surgery between 2015 and 2019: a multicentre retrospective analysis. Br J Anaesth. 2022 Sep;129(3):317-326. doi: 10.1016/j.bja.2022.05.002. Epub 2022 Jun 8.
- Background: PubMed 28973220Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.
- Background: PubMed 32925324Pancaro C, Shah N, Pasma W, Saager L, Cassidy R, van Klei W, Kooij F, Vittali D, Hollmann MW, Kheterpal S, Lirk P. Risk of Major Complications After Perioperative Norepinephrine Infusion Through Peripheral Intravenous Lines in a Multicenter Study. Anesth Analg. 2020 Oct;131(4):1060-1065. doi: 10.1213/ANE.0000000000004445.
- Background: PubMed 33976395Prowle JR, Forni LG, Bell M, Chew MS, Edwards M, Grams ME, Grocott MPW, Liu KD, McIlroy D, Murray PT, Ostermann M, Zarbock A, Bagshaw SM, Bartz R, Bell S, Bihorac A, Gan TJ, Hobson CE, Joannidis M, Koyner JL, Levett DZH, Mehta RL, Miller TE, Mythen MG, Nadim MK, Pearse RM, Rimmele T, Ronco C, Shaw AD, Kellum JA. Postoperative acute kidney injury in adult non-cardiac surgery: joint consensus report of the Acute Disease Quality Initiative and PeriOperative Quality Initiative. Nat Rev Nephrol. 2021 Sep;17(9):605-618. doi: 10.1038/s41581-021-00418-2. Epub 2021 May 11.
- Background: PubMed 27101504Mets B. Should Norepinephrine, Rather than Phenylephrine, Be Considered the Primary Vasopressor in Anesthetic Practice? Anesth Analg. 2016 May;122(5):1707-14. doi: 10.1213/ANE.0000000000001239. No abstract available.
- Background: PubMed 35504977Legrand M, Zarbock A. Ten tips to optimize vasopressors use in the critically ill patient with hypotension. Intensive Care Med. 2022 Jun;48(6):736-739. doi: 10.1007/s00134-022-06708-y. Epub 2022 May 3. No abstract available.
- Background: PubMed 31794513Mathis MR, Naik BI, Freundlich RE, Shanks AM, Heung M, Kim M, Burns ML, Colquhoun DA, Rangrass G, Janda A, Engoren MC, Saager L, Tremper KK, Kheterpal S, Aziz MF, Coffman T, Durieux ME, Levy WJ, Schonberger RB, Soto R, Wilczak J, Berman MF, Berris J, Biggs DA, Coles P, Craft RM, Cummings KC, Ellis TA 2nd, Fleishut PM, Helsten DL, Jameson LC, van Klei WA, Kooij F, LaGorio J, Lins S, Miller SA, Molina S, Nair B, Paganelli WC, Peterson W, Tom S, Wanderer JP, Wedeven C; Multicenter Perioperative Outcomes Group Investigators. Preoperative Risk and the Association between Hypotension and Postoperative Acute Kidney Injury. Anesthesiology. 2020 Mar;132(3):461-475. doi: 10.1097/ALN.0000000000003063.
- Background: PubMed 27792044Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.
- Background: PubMed 36925330Legrand M, Kothari R, Fong N, Palaniappa N, Boldt D, Chen LL, Kurien P, Gabel E, Sturgess-DaPrato J, Harhay MO, Pirracchio R, Bokoch MP; VEGA-1 trial investigators. Norepinephrine versus phenylephrine for treating hypotension during general anaesthesia in adult patients undergoing major noncardiac surgery: a multicentre, open-label, cluster-randomised, crossover, feasibility, and pilot trial. Br J Anaesth. 2023 May;130(5):519-527. doi: 10.1016/j.bja.2023.02.004. Epub 2023 Mar 14.
- Derived from this study: PubMed 41701325Joosten A, Chew MS, Futier E, Harrois A, Jacquet-Lagreze M, Legrand M, Messina A, Myles PS, Saugel B, Sessler DI, Veelo DP, Fellahi JL. Intraoperative blood pressure management in noncardiac surgery: a narrative review based on current evidence. Intensive Care Med. 2026 Mar;52(3):500-511. doi: 10.1007/s00134-026-08326-4. Epub 2026 Feb 17.
- 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.
Sachin Kheterpal, MD MBA principal investigator
University of Michigan
Matthieu Legrand, MD PhD principal investigator
University of California, San Francisco
Allison Janda, MD study director
University of Michigan
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norepinephrine and Phenylephrine in people with Anesthesia and Surgery With General Anesthesia, run by University of California, San Francisco at 10 sites in 2 countries.
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 12 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: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthieu Legrand, MD PhD (415-476-9035, matthieu.legrand@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury (AKI) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06802224, which also lists 10 linked publications.
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 26 May 2026.