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 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
130
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Mohammad Elhossieny Salama, MD
- Telefonnummer: +201016865861
- E-post: MohammadElhossieny88@med.suez.edu.eg
Studera Kontakt Backup
- Namn: Mahmoud Hosny Ahmed, MD
- Telefonnummer: +201097920831
- E-post: M.hosnawy@med.suez.edu.eg
Studieorter
-
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Ismailia Governorate
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Ismailia, Ismailia Governorate, Egypten, 41522
- Suez Canal University hospitals
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Kontakt:
- Muhammad Elhossieny Salama, MD
- Telefonnummer: 01016865861
- E-post: mohammadelhossieny88@med.suez.edu.eg
-
Huvudutredare:
- Muhammad Elhossieny Salama, MD
-
Underutredare:
- Mahmoud Hosny Ahmed, MD
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
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Continuous norepinephrine infusion administered at a fixed dose of 0.03 µg/kg/min from induction of anesthesia until skin closure.
|
|
Placebo-jämförare: 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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Total intraoperative crystalloid administration
Tidsram: 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.
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From induction of anesthesia until skin closure (intraoperative period)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Lactate Levels
Tidsram: 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
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After induction of anesthesia, at the end of surgery, and 24 hours postoperatively
|
|
Urine Output
Tidsram: From induction of anesthesia until skin closure (Intraoperative period)
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Hourly intraoperative urine output measured from urinary catheter collection and expressed as total mL/kg/hour.
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From induction of anesthesia until skin closure (Intraoperative period)
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|
Intraoperative Blood Loss
Tidsram: From surgical incision until skin closure (Intraoperative period)
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Estimated intraoperative blood loss measured in milliliters using suction canister volume after subtraction of irrigation fluids in addition to surgical field assessment.
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From surgical incision until skin closure (Intraoperative period)
|
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Number of Participants with Postoperative Pulmonary Complications
Tidsram: Within seven postoperative days
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Incidence of postoperative pulmonary complications defined according to European Perioperative Clinical Outcome (EPCO) criteria using clinical, radiological, and laboratory findings
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Within seven postoperative days
|
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Number of Participants With Acute Kidney Injury
Tidsram: Within seven postoperative days
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Incidence of acute kidney injury defined according to KDIGO criteria based on serum creatinine changes and urine output.
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Within seven postoperative days
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Duration of Rescue Norepinephrine Requirement
Tidsram: From induction of anesthesia until skin closure (Intraoperative period)
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Cumulative duration of rescue open-label norepinephrine infusion for persistent hemodynamic instability measured in minutes.
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From induction of anesthesia until skin closure (Intraoperative period)
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Duration of Intraoperative Hypotension
Tidsram: From induction of anesthesia until skin closure (Intraoperative period)
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Cumulative duration of intraoperative hypotension defined as mean arterial pressure below 65 mmHg, measured in minutes using nvasive arterial blood pressure monitoring.
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From induction of anesthesia until skin closure (Intraoperative period)
|
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Number of Participants Admitted to the Intensive Care Unit
Tidsram: Within seven postoperative days
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Number of participants requiring admission to the intensive care unit during the postoperative period.
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Within seven postoperative days
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Duration of Postoperative Hospital Stay
Tidsram: Within seven postoperative days
|
Total postoperative hospital stay measured in days during the first seven postoperative days
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Within seven postoperative days
|
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Number of Participants With Postoperative Surgical Complications
Tidsram: Within seven postoperative days
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Incidence of postoperative surgical complications assessed according to Clavien-Dindo classification grade II or higher during the first seven postoperative days.
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Within seven postoperative days
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, Christophi C, Leslie K, McGuinness S, Parke R, Serpell J, Chan MTV, Painter T, McCluskey S, Minto G, Wallace S; Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9.
- Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11.
- Persichini R, Lai C, Teboul JL, Adda I, Guerin L, Monnet X. Venous return and mean systemic filling pressure: physiology and clinical applications. Crit Care. 2022 May 24;26(1):150. doi: 10.1186/s13054-022-04024-x.
- Felippe VA, Codeceira R, Irigaray M, Sckaff M, Wegner B, Nascimento T, Darcy C, Dutra L, Santiago B, Buchmann J, Lessa MA. Non-invasive goal-directed fluid therapy with the pleth variability index (PVI): a systematic review and meta-analysis. J Clin Monit Comput. 2025 Oct;39(5):917-927. doi: 10.1007/s10877-025-01334-7. Epub 2025 Aug 8.
- Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
- Cannesson M, Le Manach Y, Hofer CK, Goarin JP, Lehot JJ, Vallet B, Tavernier B. Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness: a "gray zone" approach. Anesthesiology. 2011 Aug;115(2):231-41. doi: 10.1097/ALN.0b013e318225b80a.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
15 juli 2026
Primärt slutförande (Beräknad)
1 oktober 2026
Avslutad studie (Beräknad)
1 november 2026
Studieregistreringsdatum
Först inskickad
31 maj 2026
Först inskickad som uppfyllde QC-kriterierna
31 maj 2026
Första postat (Faktisk)
4 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 6476# (Registeridentifierare: Research Ethics Committee, Faculty of Medicine, Suez Canal University)
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