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Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loading vs Low- Concentration Carbohydrate Loading Alone in Patients Undergoing Open Gynecological Surgeries

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Apr 30, 2026 → Jan 31, 2027
See other at-risk trials from Ain Shams University

Record History

  1. Primary and study completion pushed from Apr 30, 2026 to Jan 31, 2027 Eligibility criteria expanded, about 11 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 11 words
  2. Primary and study completion dates: Dec 31, 2025 to Apr 30, 2026v15
  3. Primary and study completion dates: Mar 31, 2025 to Dec 31, 2025v14
  4. Primary and study completion dates: Sep 30, 2024 to Mar 31, 2025v13
  5. Primary and study completion dates: Apr 30, 2024 to Sep 30, 2024v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary and study completion dates: Dec 31, 2023 to Apr 30, 2024v11
  2. Primary and study completion dates: Sep 30, 2023 to Dec 31, 2023v10
  3. Primary and study completion dates: Apr 30, 2023 to Sep 30, 2023v9
  4. Primary and study completion dates: Jan 31, 2023 to Apr 30, 2023v8
  5. Primary and study completion dates: Sep 30, 2022 to Jan 31, 2023v7
  6. Primary and study completion dates: Apr 30, 2022 to Sep 30, 2022v6
  7. Primary and study completion dates: Dec 31, 2021 to Apr 30, 2022v5
  8. Primary and study completion dates: Oct 31, 2021 to Dec 31, 2021v4
  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v3 Show 1 more changeShow less
    • Study sites: 0 to 1
  10. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Surgery is known to be associated with stress response affecting in a negative way the clinical outcome and patient experience. The stress response includes both sympathetic nervous system activation and systemic inflammatory response. The pituitary- sympathetic one leads to a number of metabolic changes as hyperglycemia, nitrogen loss and lipolysis on the other hand the systemic inflammatory response aggravates the perioperative metabolic changes. One of components of ERAS is preoperative carbohydrate load. Oral carbohydrate was associated with attenuation of the postoperative metabolic stress response. Nitrate rich drinks before exercises have a promising impact due to improving blood flow, mitochondrial efficiency, glucose uptake and the sarcoplasmic calcium handling all of which maximize resistance to fatigue and improved exercise performance.
Trial Details
NCT Number NCT04962776
Lead Sponsor Ain Shams University
Conditions Length of Hospital Stay
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov