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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 (PRO STRESS)

31. maj 2026 opdateret af: Suez Canal University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

130

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Egypten
    • Ismailia Governorate
      • Ismailia, Ismailia Governorate, Egypten, 41522
        • Suez Canal University Hospitals
        • Kontakt:
        • Ledende efterforsker:
          • Muhammad Elhossieny Salama, MD
        • Underforsker:
          • Mahmoud Hosny Ahmed, MD

Deltagelseskriterier

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Berettigelseskriterier

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Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Norepinephrine Group
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.
Medicin: Norepinephrine
Continuous norepinephrine infusion administered at a fixed dose of 0.03 µg/kg/min from induction of anesthesia until skin closure.
Placebo komparator: Control Group
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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total intraoperative crystalloid administration
Tidsramme: 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.
From induction of anesthesia until skin closure (intraoperative period)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Pulmonary Complications
Tidsramme: Within seven postoperative days
Incidence of postoperative pulmonary complications defined according to European Perioperative Clinical Outcome (EPCO) criteria using clinical, radiological, and laboratory findings
Within seven postoperative days
Acute Kidney Injury
Tidsramme: Within seven postoperative days
Incidence of acute kidney injury defined according to KDIGO criteria based on serum creatinine changes and urine output.
Within seven postoperative days
Lactate Levels
Tidsramme: 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
After induction of anesthesia, at the end of surgery, and 24 hours postoperatively
Urine Output
Tidsramme: 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.
From induction of anesthesia until skin closure (Intraoperative period)
Intraoperative Blood Loss
Tidsramme: 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.
From surgical incision until skin closure (Intraoperative period)
Rescue Norepinephrine Requirement
Tidsramme: From induction of anesthesia until skin closure (Intraoperative period)
Requirement for rescue open-label norepinephrine infusion for persistent hemodynamic instability including cumulative duration of infusion measured in minute
From induction of anesthesia until skin closure (Intraoperative period)
Duration of Intraoperative Hypotension
Tidsramme: 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 and recorded from invasive arterial blood pressure monitoring.
From induction of anesthesia until skin closure (Intraoperative period)
Intensive Care Unit Admission
Tidsramme: Within seven postoperative days
Admission to the intensive care unit during the postoperative period.
Within seven postoperative days
Length of Hospital Stay
Tidsramme: Within seven postoperative days
Total postoperative hospital stay measured in days during the first seven postoperative days
Within seven postoperative days
Postoperative Surgical Complications
Tidsramme: 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.
Within seven postoperative days

Samarbejdspartnere og efterforskere

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Sponsor

Suez Canal University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

23. maj 2026

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

1. november 2026

Datoer for studieregistrering

Først indsendt

31. maj 2026

Først indsendt, der opfyldte QC-kriterier

31. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 6476# (Registry Identifier: Research Ethics Committee, Faculty of Medicine, Suez Canal University)

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