Secondary PeritonitisPhase 4NCT07529795
Low-dose Norepinephrine Infusion for Prevention of Post-induction Hypotension in Emergency Surgery for Peritonitis
A Phase 4 study testing Norepinephrine (0.05 μg/kg/min) in people with Secondary Peritonitis and Post-induction Hypotension, run by Bach Mai Hospital at 1 site in Vietnam.
Trial summary
This study tests whether giving a low-dose norepinephrine infusion just before induction of anesthesia can reduce low blood pressure during emergency surgery for peritonitis. Adults with secondary peritonitis who are scheduled for emergency surgery and have stable blood pressure after initial resuscitation will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Peritonitis, Post-induction Hypotension
- What is being tested?
- Norepinephrine (0.05 μg/kg/min)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Apr 2026to Oct 2026
- 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
- Adults aged 18 years or older.
- Secondary peritonitis requiring emergency surgery under general anesthesia with endotracheal intubation.
- Planned induction with fentanyl, propofol, and rocuronium according to the study protocol.
- Hemodynamically stabilized after initial resuscitation, with MAP at least 65 mmHg and no ongoing vasopressor infusion before induction.
- ASA physical status I to III.
- Written informed consent from the participant or a legally authorized representative.
Who cannot join
- Allergy or contraindication to norepinephrine, propofol, fentanyl, or rocuronium.
- Severe cardiovascular disease likely to confound hemodynamic assessment, including decompensated heart failure, acute coronary syndrome, severe arrhythmia, severe valvular disease, or major cardiomyopathy.
- Ongoing vasopressor therapy before induction.
- Shock before surgery, including hypovolemic, septic, or cardiogenic shock.
- Severe hypertension before induction (systolic blood pressure >180 mmHg or mean arterial pressure >110 mmHg).
- Severe peripheral vascular disease or clinically significant limb ischemia.
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- Current monoamine oxidase inhibitor use.
- Pregnancy or breastfeeding.
- Contraindication to arterial catheter placement.
- Refusal of consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital
Hanoi
Center for Anesthesia and Intensive Care, Bach Mai Hospital. Center for Anesthesia and Intensive Care, Bach Mai Hospital., +084869587720, trungtamgaymehoisuc@bachmai.edu.vn
About this study
Official title: Protocolized Low-dose Norepinephrine Infusion for Prevention of Post-induction Hypotension in Adults Undergoing Emergency Surgery for Secondary Peritonitis: A Randomized Double-blind Placebo-controlled Trial
This study tests whether giving a low-dose norepinephrine infusion just before induction of anesthesia can reduce low blood pressure during emergency surgery for peritonitis. Adults with secondary peritonitis who are scheduled for emergency surgery and have stable blood pressure after initial resuscitation will be randomly assigned to receive either norepinephrine or placebo (normal saline) during induction of anesthesia. The main outcome is the cumulative time spent with mean arterial pressure (MAP) below 65 mmHg from the start of propofol administration to 10 minutes after endotracheal intubation. The study will also evaluate rescue vasopressor use, heart rate changes, drug-related adverse events, and selected early postoperative outcomes.
Read the detailed description
The study is a single-center, randomized, double-blind, placebo-controlled interventional trial conducted at the Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital, Hanoi, Vietnam.
Adults undergoing emergency surgery for secondary peritonitis often have marked hemodynamic vulnerability during induction of general anesthesia because of systemic inflammation, vasodilation, capillary leak, and relative hypovolemia. Propofol-based induction may further reduce arterial pressure and organ perfusion in this setting.
Participants who meet eligibility criteria and have a mean arterial pressure (MAP) of at least 65 mmHg after initial resuscitation, without ongoing vasopressor support, will be enrolled and randomized 1:1 to a norepinephrine infusion group or a placebo group.
In the intervention group, norepinephrine will be infused at 0.05 micrograms/kg/min starting 3 minutes before fentanyl. In the placebo group, 0.9% sodium chloride will be infused with the same presentation, timing, and pump settings.
All participants will undergo a standardized induction protocol with fentanyl, titrated propofol, rocuronium, arterial line monitoring before induction, and protocolized hemodynamic rescue treatment.
The primary endpoint is the cumulative duration of MAP below 65 mmHg during the induction-intubation window, defined from the start of propofol administration to 10 minutes after endotracheal intubation. Secondary endpoints include the incidence of MAP below 65 and below 55 mmHg, the largest decrease in MAP from baseline, heart-rate changes, rescue vasopressor requirements, atropine use, and predefined early postoperative outcomes.
- Conditions
- Secondary Peritonitis, Post-induction Hypotension
- Being tested
- Norepinephrine (0.05 μg/kg/min), Placebo
- Keywords
- Emergency surgery, General anesthesia, Norepinephrine, Noradrenaline, Induction hypotension, Mean arterial pressure
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norepinephrine (0.05 μg/kg/min)Drug
Norepinephrine prepared in a blinded syringe and infused continuously at 0.05 micrograms/kg/min starting 3 minutes before fentanyl during induction of general anesthesia. Infusion is adjusted or temporarily stopped according to the protocol-defined hemodynamic safety algorithm.
PlaceboOther
Placebo: 0.9% Sodium Chloride prepared in a blinded syringe and administered with the same timing, presentation, and pump settings as the active study drug.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose norepinephrine infusion | Experimental | Participants receive a norepinephrine infusion at 0.05 micrograms/kg/min starting 3 minutes before fentanyl during standardized induction of general anesthesia. Receives: Drug: Norepinephrine (0.05 μg/kg/min) |
| 0.9% sodium chloride infusion | Placebo comparator | Participants receive 0.9% sodium chloride with the same presentation, timing, and infusion settings as the intervention arm during standardized induction of general anesthesia. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative duration of MAP below 65 mmHg during induction
Total time with mean arterial pressure below 65 mmHg, derived from time-stamped arterial line data after removal of artifacts.
Measured: From start of propofol administration to 10 minutes after endotracheal intubation
Secondary outcomes (13)
Incidence of MAP below 65 mmHg
Proportion of participants with at least one episode of MAP below 65 mmHg.
Measured: From start of propofol administration to 10 minutes after endotracheal intubation
Incidence of severe hypotension (MAP below 55 mmHg)
Proportion of participants with at least one episode of MAP below 55 mmHg.
Measured: From start of propofol administration to 10 minutes after endotracheal intubation
Largest decrease in MAP from baseline
Maximum absolute and relative reduction in MAP compared with baseline.
Measured: From baseline before study-drug infusion to 10 minutes after endotracheal intubation
Number of Participants Requiring Rescue Vasopressor
Number of participants who receive any rescue vasopressor to treat hypotension during the induction-intubation study window.
Measured: From baseline before study-drug infusion to 10 minutes after endotracheal intubation
Number of Participants With Bradycardia
Number of participants with bradycardia during the induction-intubation study window. Bradycardia should be defined according to the protocol-specified threshold
Measured: From start of propofol administration to 10 minutes after endotracheal intubation
Postoperative lactate concentration
Arterial or venous lactate concentration used as an exploratory marker of tissue perfusion and physiologic recovery
Measured: Preoperative baseline and within 24 hours after surgery
Total Rescue Vasopressor Dose
Total dose of rescue vasopressor administered to treat hypotension during the induction-intubation study window.
Measured: From baseline before study-drug infusion to 10 minutes after endotracheal intubation
Number of Participants With Tachycardia
Number of participants with tachycardia during the induction-intubation study window. Tachycardia should be defined according to the protocol-specified threshold.
Measured: From start of propofol administration to 10 minutes after endotracheal intubation
Number of Participants Requiring Atropine
Number of participants who receive atropine according to the protocol-defined criteria during the induction-intubation study window.
Measured: From start of propofol administration to 10 minutes after endotracheal intubation
Number of Participants With Clinically Significant Arrhythmias
Number of participants with clinically significant arrhythmias during the induction-intubation study window.
Measured: From start of propofol administration to 10 minutes after endotracheal intubation
Number of Participants Admitted to the Intensive Care Unit After Surgery
Number of participants transferred to the intensive care unit (ICU) after surgery.
Measured: From end of surgery to hospital discharge
Number of Participants With Early Postoperative Complications
Number of participants with predefined early postoperative complications after surgery.
Measured: From end of surgery to hospital discharge
Postoperative Length of Stay
Postoperative length of hospital stay from the end of surgery until hospital discharge.
Measured: From end of surgery to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary PeritonitisStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bach Mai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Toan Thang, Bach Mai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529795
- Sponsor's protocol ID
- TTGMHS-NA-PP-2026-02
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have not yet determined whether de-identified individual participant data will be shared. Any future data sharing decision will depend on institutional policy, ethics approval requirements, and participant privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocolized Low-dose Norepinephrine Infusion for Prevention of Post-induction Hypotension in Adults Undergoing Emergency Surgery for Secondary Peritonitis: A Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07529795
- Acronym / sponsor ID
- TTGMHS-NA-PP-2026-02
- Conditions
- Secondary Peritonitis, Post-induction Hypotension
- Keywords
- Emergency surgery, General anesthesia, Norepinephrine, Noradrenaline, Induction hypotension, Mean arterial pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bach Mai HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 14 Apr 2026 (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.
This study tests whether giving a low-dose norepinephrine infusion just before induction of anesthesia can reduce low blood pressure during emergency surgery for peritonitis. Adults with secondary peritonitis who are scheduled for emergency surgery and have stable blood pressure after initial resuscitation will be randomly assigned to receive either norepinephrine or placebo (normal saline) during induction of anesthesia. The main outcome is the cumulative time spent with mean arterial pressure (MAP) below 65 mmHg from the start of propofol administration to 10 minutes after endotracheal intubation. The study will also evaluate rescue vasopressor use, heart rate changes, drug-related adverse events, and selected early postoperative outcomes.
Detailed description
The study is a single-center, randomized, double-blind, placebo-controlled interventional trial conducted at the Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital, Hanoi, Vietnam.
Adults undergoing emergency surgery for secondary peritonitis often have marked hemodynamic vulnerability during induction of general anesthesia because of systemic inflammation, vasodilation, capillary leak, and relative hypovolemia. Propofol-based induction may further reduce arterial pressure and organ perfusion in this setting.
Participants who meet eligibility criteria and have a mean arterial pressure (MAP) of at least 65 mmHg after initial resuscitation, without ongoing vasopressor support, will be enrolled and randomized 1:1 to a norepinephrine infusion group or a placebo group.
In the intervention group, norepinephrine will be infused at 0.05 micrograms/kg/min starting 3 minutes before fentanyl. In the placebo group, 0.9% sodium chloride will be infused with the same presentation, timing, and pump settings.
All participants will undergo a standardized induction protocol with fentanyl, titrated propofol, rocuronium, arterial line monitoring before induction, and protocolized hemodynamic rescue treatment.
The primary endpoint is the cumulative duration of MAP below 65 mmHg during the induction-intubation window, defined from the start of propofol administration to 10 minutes after endotracheal intubation. Secondary endpoints include the incidence of MAP below 65 and below 55 mmHg, the largest decrease in MAP from baseline, heart-rate changes, rescue vasopressor requirements, atropine use, and predefined early postoperative outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose norepinephrine infusion | Experimental | Drug: Norepinephrine (0.05 μg/kg/min)Participants receive a norepinephrine infusion at 0.05 micrograms/kg/min starting 3 minutes before fentanyl during standardized induction of general anesthesia. |
| 0.9% sodium chloride infusion | Placebo comparator | Other: PlaceboParticipants receive 0.9% sodium chloride with the same presentation, timing, and infusion settings as the intervention arm during standardized induction of general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older.
- Secondary peritonitis requiring emergency surgery under general anesthesia with endotracheal intubation.
- Planned induction with fentanyl, propofol, and rocuronium according to the study protocol.
- Hemodynamically stabilized after initial resuscitation, with MAP at least 65 mmHg and no ongoing vasopressor infusion before induction.
- ASA physical status I to III.
Key exclusion criteria (10 listed)
- Allergy or contraindication to norepinephrine, propofol, fentanyl, or rocuronium.
- Severe cardiovascular disease likely to confound hemodynamic assessment, including decompensated heart failure, acute coronary syndrome, severe arrhythmia, severe valvular disease, or major cardiomyopathy.
- Ongoing vasopressor therapy before induction.
- Shock before surgery, including hypovolemic, septic, or cardiogenic shock.
- Severe hypertension before induction (systolic blood pressure >180 mmHg or mean arterial pressure >110 mmHg).
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 |
|---|---|---|
| Norepinephrine (0.05 μg/kg/min)Norepinephrine prepared in a blinded syringe and infused continuously at 0.05 micrograms/kg/min starting 3 minutes before fentanyl during induction of general anesthesia. Infusion is adjusted or temporarily stopped according to the protocol-defined hemodynamic safety algorithm. | Drug | Low-dose norepinephrine infusion |
| PlaceboPlacebo: 0.9% Sodium Chloride prepared in a blinded syringe and administered with the same timing, presentation, and pump settings as the active study drug. | Other | 0.9% sodium chloride infusion |
Primary outcome
Cumulative duration of MAP below 65 mmHg during induction
Time frame: From start of propofol administration to 10 minutes after endotracheal intubation
Total time with mean arterial pressure below 65 mmHg, derived from time-stamped arterial line data after removal of artifacts.
13 secondary outcomes
Incidence of MAP below 65 mmHg
Time frame: From start of propofol administration to 10 minutes after endotracheal intubation
Incidence of severe hypotension (MAP below 55 mmHg)
Time frame: From start of propofol administration to 10 minutes after endotracheal intubation
Largest decrease in MAP from baseline
Time frame: From baseline before study-drug infusion to 10 minutes after endotracheal intubation
Number of Participants Requiring Rescue Vasopressor
Time frame: From baseline before study-drug infusion to 10 minutes after endotracheal intubation
Number of Participants With Bradycardia
Time frame: From start of propofol administration to 10 minutes after endotracheal intubation
Postoperative lactate concentration
Time frame: Preoperative baseline and within 24 hours after surgery
Total Rescue Vasopressor Dose
Time frame: From baseline before study-drug infusion to 10 minutes after endotracheal intubation
Number of Participants With Tachycardia
Time frame: From start of propofol administration to 10 minutes after endotracheal intubation
Number of Participants Requiring Atropine
Time frame: From start of propofol administration to 10 minutes after endotracheal intubation
Number of Participants With Clinically Significant Arrhythmias
Time frame: From start of propofol administration to 10 minutes after endotracheal intubation
Number of Participants Admitted to the Intensive Care Unit After Surgery
Time frame: From end of surgery to hospital discharge
Number of Participants With Early Postoperative Complications
Time frame: From end of surgery to hospital discharge
Postoperative Length of Stay
Time frame: From end of surgery to hospital discharge
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 14 Apr 2026.
- Individual participant dataSharing planned: Undecided. The investigators have not yet determined whether de-identified individual participant data will be shared. Any future data sharing decision will depend on institutional policy, ethics approval requirements, and participant privacy considerations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norepinephrine (0.05 μg/kg/min) in people with Secondary Peritonitis and Post-induction Hypotension, run by Bach Mai Hospital at 1 site in Vietnam.
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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. Some participants in this study may receive a placebo. 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 Thang Toan Nguyen, PhD (+084916874795, nguyentoanthang@hmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative duration of MAP below 65 mmHg during induction (time frame: From start of propofol administration to 10 minutes after endotracheal intubation). 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 14 Apr 2026.