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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2026-07-13
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
Interventions
- DRUG
-
Norepinephrine
Continuous norepinephrine infusion administered at a fixed dose of 0.03 µg/kg/min from induction of anesthesia until skin closure.
- OTHER
-
Placebo
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.
Sponsors & Collaborators
-
Suez Canal University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-15
- Primary Completion
- 2026-10-31
- Completion
- 2026-11-30
Countries
- Egypt
Study Locations
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