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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuez Canal University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Norepinephrine GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total intraoperative crystalloid administration

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

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

Secondary outcomes

1

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

Time frame
Within seven postoperative days
2

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.

Time frame
Within seven postoperative days
3

Lactate Levels

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

Time frame
After induction of anesthesia, at the end of surgery, and 24 hours postoperatively
4

Urine Output

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: