Intraoperative HypotensionPRO STRESSNCT07627360
PRO STRESS Trial: Proactive Low-Dose Norepinephrine to Reduce Intraoperative Fluid Administration in Patients at High-Risk for Postoperative Pulmonary Complications Undergoing Laparoscopic Abdominal Surgery
A study testing Norepinephrine in people with Intraoperative Hypotension and Postoperative Pulmonary Complications (PPCs), run by Suez Canal University at 1 site in Egypt.
Trial summary
Intraoperative hypotension is commonly treated with fluid administration; however, excessive fluid therapy may contribute to postoperative pulmonary complications. This randomized double-blind controlled trial evaluates whether proactive administration of fixed low-dose norepinephrine reduces intraoperative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Hypotension, Postoperative Pulmonary Complications (PPCs), Fluid Over-load
- What is being tested?
- Norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2026to Nov 2026
- Phase
- Interventional
- 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
- Adult patients aged 18 years or older.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Scheduled for elective laparoscopic major abdominal surgery under general anesthesia with an expected duration greater than 2 hours.
- Patients with ARISCAT score ≥ 45 indicating high risk for postoperative pulmonary complications.
Who cannot join
- Known hypersensitivity to norepinephrine.
- Severe left ventricular dysfunction with ejection fraction < 35%.
- Significant cardiac arrhythmia.
- Uncontrolled hypertension defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg.
- End-stage renal disease.
- Requirement for vasopressor support before induction of anesthesia.
- Emergency surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Suez Canal University Hospitals
Ismailia, Ismailia Governorate, 41522
Muhammad Elhossieny Salama, MD, 01016865861, mohammadelhossieny88@med.suez.edu.eg
Muhammad Elhossieny Salama, MD
About this study
Official title: Proactive Low-Dose Norepinephrine to Reduce Intraoperative Fluid Administration in Patients at High-Risk for Postoperative Pulmonary Complications Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial
Intraoperative hypotension is commonly treated with fluid administration; however, excessive fluid therapy may contribute to postoperative pulmonary complications. This randomized double-blind controlled trial evaluates whether proactive administration of fixed low-dose norepinephrine reduces intraoperative crystalloid administration while maintaining hemodynamic stability in high-risk patients undergoing laparoscopic abdominal surgery. One hundred and thirty patients will be randomized to receive either norepinephrine infusion (0.03 µg/kg/min) or placebo from induction until skin closure within a protocolized hemodynamic strategy guided by mean arterial pressure and pulse pressure variation.
- Being tested
- Norepinephrine, Placebo
- Keywords
- Norepinephrine, Fluid Therapy, Pulmonary Complications, Abdominal Surgery, Vasopressor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Continuous norepinephrine infusion administered at a fixed dose of 0.03 µg/kg/min from induction of anesthesia until skin closure.
PlaceboOther
Equivalent volume normal saline infusion administered from induction of anesthesia until skin closure at the same infusion rate as the active intervention to maintain blinding within a protocolized hemodynamic management strategy.
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine Group | Experimental | Participants will receive continuous norepinephrine infusion at a fixed dose of 0.03 µg/kg/min initiated immediately after induction of anesthesia and continued until skin closure within a protocolized hemodynamic management strategy. Receives: Drug: Norepinephrine |
| Control Group | Placebo comparator | Participants will receive an equivalent volume normal saline infusion initiated immediately after induction of anesthesia and continued until skin closure within the same protocolized hemodynamic management strategy. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intraoperative crystalloid administration
Total volume of crystalloid administered intraoperatively from induction of anesthesia until skin closure, measured in milliliters.
Measured: From induction of anesthesia until skin closure (intraoperative period)
Secondary outcomes (10)
Number of Participants with Postoperative Pulmonary Complications
Incidence of postoperative pulmonary complications defined according to European Perioperative Clinical Outcome (EPCO) criteria using clinical, radiological, and laboratory findings
Measured: Within seven postoperative days
Number of Participants With Acute Kidney Injury
Incidence of acute kidney injury defined according to KDIGO criteria based on serum creatinine changes and urine output.
Measured: Within seven postoperative days
Lactate Levels
Arterial lactate concentration measured in mmol/L serially during the perioperative period
Measured: After induction of anesthesia, at the end of surgery, and 24 hours postoperatively
Urine Output
Hourly intraoperative urine output measured from urinary catheter collection and expressed as total mL/kg/hour.
Measured: From induction of anesthesia until skin closure (Intraoperative period)
Intraoperative Blood Loss
Estimated intraoperative blood loss measured in milliliters using suction canister volume after subtraction of irrigation fluids in addition to surgical field assessment.
Measured: From surgical incision until skin closure (Intraoperative period)
Duration of Rescue Norepinephrine Requirement
Cumulative duration of rescue open-label norepinephrine infusion for persistent hemodynamic instability measured in minutes.
Measured: From induction of anesthesia until skin closure (Intraoperative period)
Duration of Intraoperative Hypotension
Cumulative duration of intraoperative hypotension defined as mean arterial pressure below 65 mmHg, measured in minutes using nvasive arterial blood pressure monitoring.
Measured: From induction of anesthesia until skin closure (Intraoperative period)
Number of Participants Admitted to the Intensive Care Unit
Number of participants requiring admission to the intensive care unit during the postoperative period.
Measured: Within seven postoperative days
Duration of Postoperative Hospital Stay
Total postoperative hospital stay measured in days during the first seven postoperative days
Measured: Within seven postoperative days
Number of Participants With Postoperative Surgical Complications
Incidence of postoperative surgical complications assessed according to Clavien-Dindo classification grade II or higher during the first seven postoperative days.
Measured: Within seven postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start15 Jul 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intraoperative 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627360
- Sponsor's protocol ID
- 6476#
- Other IDs
- 6476#
- Acronym
- PRO STRESS
- Status last verified
- Jul 2026
- First submitted
- 31 May 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Persichini R, Lai C, Teboul JL, Adda I, Guerin L, Monnet X. Venous return and mean systemic filling pressure: physiology and clinical applications. Crit Care. 2022 May 24;26(1):150. doi: 10.1186/s13054-022-04024-x.
PubMed 35610620Felippe VA, Codeceira R, Irigaray M, Sckaff M, Wegner B, Nascimento T, Darcy C, Dutra L, Santiago B, Buchmann J, Lessa MA. Non-invasive goal-directed fluid therapy with the pleth variability index (PVI): a systematic review and meta-analysis. J Clin Monit Comput. 2025 Oct;39(5):917-927. doi: 10.1007/s10877-025-01334-7. Epub 2025 Aug 8.
PubMed 40778974Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11.
PubMed 26162676Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
PubMed 21045639Cannesson M, Le Manach Y, Hofer CK, Goarin JP, Lehot JJ, Vallet B, Tavernier B. Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness: a "gray zone" approach. Anesthesiology. 2011 Aug;115(2):231-41. doi: 10.1097/ALN.0b013e318225b80a.
PubMed 21705869Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, Christophi C, Leslie K, McGuinness S, Parke R, Serpell J, Chan MTV, Painter T, McCluskey S, Minto G, Wallace S; Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9.
PubMed 29742967
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Low-Dose Norepinephrine to Reduce Intraoperative Fluid Administration in Patients at High-Risk for Postoperative Pulmonary Complications Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07627360
- Acronym / sponsor ID
- PRO STRESS / 6476#
- Keywords
- Norepinephrine, Fluid Therapy, Pulmonary Complications, Abdominal Surgery, Vasopressor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 4 Jun 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.
Intraoperative hypotension is commonly treated with fluid administration; however, excessive fluid therapy may contribute to postoperative pulmonary complications. This randomized double-blind controlled trial evaluates whether proactive administration of fixed low-dose norepinephrine reduces intraoperative crystalloid administration while maintaining hemodynamic stability in high-risk patients undergoing laparoscopic abdominal surgery. One hundred and thirty patients will be randomized to receive either norepinephrine infusion (0.03 µg/kg/min) or placebo from induction until skin closure within a protocolized hemodynamic strategy guided by mean arterial pressure and pulse pressure variation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine Group | Experimental | Drug: NorepinephrineParticipants will receive continuous norepinephrine infusion at a fixed dose of 0.03 µg/kg/min initiated immediately after induction of anesthesia and continued until skin closure within a protocolized hemodynamic management strategy. |
| Control Group | Placebo comparator | Other: PlaceboParticipants will receive an equivalent volume normal saline infusion initiated immediately after induction of anesthesia and continued until skin closure within the same protocolized hemodynamic management strategy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or older.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Scheduled for elective laparoscopic major abdominal surgery under general anesthesia with an expected duration greater than 2 hours.
- Patients with ARISCAT score ≥ 45 indicating high risk for postoperative pulmonary complications.
Key exclusion criteria (7 listed)
- Known hypersensitivity to norepinephrine.
- Severe left ventricular dysfunction with ejection fraction < 35%.
- Significant cardiac arrhythmia.
- Uncontrolled hypertension defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg.
- End-stage renal disease.
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 |
|---|---|---|
| NorepinephrineContinuous norepinephrine infusion administered at a fixed dose of 0.03 µg/kg/min from induction of anesthesia until skin closure. | Drug | Norepinephrine Group |
| PlaceboEquivalent volume normal saline infusion administered from induction of anesthesia until skin closure at the same infusion rate as the active intervention to maintain blinding within a protocolized hemodynamic management strategy. | Other | Control Group |
Primary outcome
Total intraoperative crystalloid administration
Time frame: From induction of anesthesia until skin closure (intraoperative period)
Total volume of crystalloid administered intraoperatively from induction of anesthesia until skin closure, measured in milliliters.
10 secondary outcomes
Number of Participants with Postoperative Pulmonary Complications
Time frame: Within seven postoperative days
Number of Participants With Acute Kidney Injury
Time frame: Within seven postoperative days
Lactate Levels
Time frame: After induction of anesthesia, at the end of surgery, and 24 hours postoperatively
Urine Output
Time frame: From induction of anesthesia until skin closure (Intraoperative period)
Intraoperative Blood Loss
Time frame: From surgical incision until skin closure (Intraoperative period)
Duration of Rescue Norepinephrine Requirement
Time frame: From induction of anesthesia until skin closure (Intraoperative period)
Duration of Intraoperative Hypotension
Time frame: From induction of anesthesia until skin closure (Intraoperative period)
Number of Participants Admitted to the Intensive Care Unit
Time frame: Within seven postoperative days
Duration of Postoperative Hospital Stay
Time frame: Within seven postoperative days
Number of Participants With Postoperative Surgical Complications
Time frame: Within seven postoperative 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 13 Jul 2026.
- Results publication: PubMed 35610620Persichini R, Lai C, Teboul JL, Adda I, Guerin L, Monnet X. Venous return and mean systemic filling pressure: physiology and clinical applications. Crit Care. 2022 May 24;26(1):150. doi: 10.1186/s13054-022-04024-x.
- Results publication: PubMed 40778974Felippe VA, Codeceira R, Irigaray M, Sckaff M, Wegner B, Nascimento T, Darcy C, Dutra L, Santiago B, Buchmann J, Lessa MA. Non-invasive goal-directed fluid therapy with the pleth variability index (PVI): a systematic review and meta-analysis. J Clin Monit Comput. 2025 Oct;39(5):917-927. doi: 10.1007/s10877-025-01334-7. Epub 2025 Aug 8.
- Results publication: PubMed 26162676Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11.
- Results publication: PubMed 21045639Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
- Results publication: PubMed 21705869Cannesson M, Le Manach Y, Hofer CK, Goarin JP, Lehot JJ, Vallet B, Tavernier B. Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness: a "gray zone" approach. Anesthesiology. 2011 Aug;115(2):231-41. doi: 10.1097/ALN.0b013e318225b80a.
- Results publication: PubMed 29742967Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, Christophi C, Leslie K, McGuinness S, Parke R, Serpell J, Chan MTV, Painter T, McCluskey S, Minto G, Wallace S; Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine in people with Intraoperative Hypotension and Postoperative Pulmonary Complications (PPCs), run by Suez Canal University at 1 site in Egypt.
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 4 inclusion and 7 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 13 Jul 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 Egypt. 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.
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 Mohammad Elhossieny Salama, MD (+201016865861, MohammadElhossieny88@med.suez.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total intraoperative crystalloid administration (time frame: From induction of anesthesia until skin closure (intraoperative period)). 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 NCT07627360, which also lists 6 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 13 Jul 2026.