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NCT Number: NCT07627360

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University Hospitals

Ismailia, Ismailia Governorate, 41522, Egypt

Location contact

Mahmoud Hosny Ahmed, MD

SUB_INVESTIGATOR

Muhammad Elhossieny Salama, MD

CONTACT

[email protected]

01016865861

Muhammad Elhossieny Salama, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

norepinephrine

Drug

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of Participants with Postoperative Pulmonary Complications

    Time frame: Within seven postoperative days

    Incidence of postoperative pulmonary complications defined according to European Perioperative Clinical Outcome (EPCO) criteria using clinical, radiological, and laboratory findings

  2. Number of Participants With Acute Kidney Injury

    Time frame: Within seven postoperative days

    Incidence of acute kidney injury defined according to KDIGO criteria based on serum creatinine changes and urine output.

  3. Lactate Levels

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

    Arterial lactate concentration measured in mmol/L serially during the perioperative period

  4. Urine Output

    Time frame: From induction of anesthesia until skin closure (Intraoperative period)

    Hourly intraoperative urine output measured from urinary catheter collection and expressed as total mL/kg/hour.

  5. Intraoperative Blood Loss

    Time frame: From surgical incision until skin closure (Intraoperative period)

    Estimated intraoperative blood loss measured in milliliters using suction canister volume after subtraction of irrigation fluids in addition to surgical field assessment.

  6. Duration of Rescue Norepinephrine Requirement

    Time frame: From induction of anesthesia until skin closure (Intraoperative period)

    Cumulative duration of rescue open-label norepinephrine infusion for persistent hemodynamic instability measured in minutes.

  7. Duration of Intraoperative Hypotension

    Time frame: From induction of anesthesia until skin closure (Intraoperative period)

    Cumulative duration of intraoperative hypotension defined as mean arterial pressure below 65 mmHg, measured in minutes using nvasive arterial blood pressure monitoring.

  8. Number of Participants Admitted to the Intensive Care Unit

    Time frame: Within seven postoperative days

    Number of participants requiring admission to the intensive care unit during the postoperative period.

  9. Duration of Postoperative Hospital Stay

    Time frame: Within seven postoperative days

    Total postoperative hospital stay measured in days during the first seven postoperative days

  10. Number of Participants With Postoperative Surgical Complications

    Time frame: Within seven postoperative days

    Incidence of postoperative surgical complications assessed according to Clavien-Dindo classification grade II or higher during the first seven postoperative days.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Hosny Ahmed, MD

CONTACT

[email protected]

+201097920831

Mohammad Elhossieny Salama, MD

CONTACT

[email protected]

+201016865861

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study 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

Acronym: PRO STRESS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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