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

NCT07627360 | Not Yet Recruiting

• 1 other identifier: 6476#
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Intraoperative Hypotension; Postoperative Pulmonary Complications (PPCs); Fluid Over-load

Keywords

Norepinephrine; Fluid Therapy; Pulmonary Complications; Abdominal Surgery; Vasopressor

Outcome Measures

Primary Outcomes (1)

• Total intraoperative crystalloid administration

  Total volume of crystalloid administered intraoperatively from induction of anesthesia until skin closure, measured in milliliters.

  From induction of anesthesia until skin closure (intraoperative period)

Secondary Outcomes (10)

• Postoperative Pulmonary Complications

  Within seven postoperative days

• Acute Kidney Injury

  Within seven postoperative days

• Lactate Levels

  After induction of anesthesia, at the end of surgery, and 24 hours postoperatively

• Urine Output

  From induction of anesthesia until skin closure (Intraoperative period)

• Intraoperative Blood Loss

  From surgical incision until skin closure (Intraoperative period)

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Norepinephrine DRUG

Continuous norepinephrine infusion administered at a fixed dose of 0.03 µg/kg/min from induction of anesthesia until skin closure.

Norepinephrine Group

Placebo OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University Hospitals

Ismailia, Ismailia Governorate, 41522, Egypt

Location

Related Publications (6)

• 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.

  PMID: 35610620 RESULT

• Felippe 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.

  PMID: 40778974 RESULT

• Cecconi 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.

  PMID: 26162676 RESULT

• Canet 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.

  PMID: 21045639 RESULT

• Cannesson 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.

  PMID: 21705869 RESULT

• Myles 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.

  PMID: 29742967 RESULT

MeSH Terms

Interventions

Norepinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Mohammad Elhossieny Salama, MD

CONTACT

+201016865861; MohammadElhossieny88@med.suez.edu.eg

Mahmoud Hosny Ahmed, MD

CONTACT

+201097920831; M.hosnawy@med.suez.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 4, 2026
• Study Start: May 23, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)