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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)

10. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

130

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Egypt
    • Ismailia Governorate
      • Ismailia, Ismailia Governorate, Egypt, 41522
        • Suez Canal University hospitals
        • Ta kontakt med:
        • Hovedetterforsker:
          • Muhammad Elhossieny Salama, MD
        • Underetterforsker:
          • Mahmoud Hosny Ahmed, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
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)
Number of Participants with 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
Number of Participants With 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
Duration of Rescue Norepinephrine Requirement
Tidsramme: From induction of anesthesia until skin closure (Intraoperative period)
Cumulative duration of rescue open-label norepinephrine infusion for persistent hemodynamic instability measured in minutes.
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 using nvasive arterial blood pressure monitoring.
From induction of anesthesia until skin closure (Intraoperative period)
Number of Participants Admitted to the Intensive Care Unit
Tidsramme: Within seven postoperative days
Number of participants requiring admission to the intensive care unit during the postoperative period.
Within seven postoperative days
Duration of Postoperative Hospital Stay
Tidsramme: Within seven postoperative days
Total postoperative hospital stay measured in days during the first seven postoperative days
Within seven postoperative days
Number of Participants With 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

Samarbeidspartnere og etterforskere

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Sponsor

Suez Canal University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juli 2026

Primær fullføring (Antatt)

1. oktober 2026

Studiet fullført (Antatt)

1. november 2026

Datoer for studieregistrering

Først innsendt

31. mai 2026

Først innsendt som oppfylte QC-kriteriene

31. mai 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

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