Intraoperative Fluid Management Guided by Internal Jugular Vein on Postoperative Complications in Abdominal Surgeries

NCT07041021 | Recruiting

• 1 other identifier: 5988#
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

This study investigates the role of respiratory variation in the internal jugular vein as a tool for intraoperative fluid management during abdominal surgeries under general anesthesia. The purpose of this clinical trial is to reduce postoperative complications and improve patient outcomes through proper intraoperative fluid management. The main question it aims to answer is: Can intraoperative fluid management guided by the respiratory variation of the internal jugular vein during abdominal surgeries reduce postoperative complications? Research Hypothesis (Alternative Hypothesis): We hypothesize that fluid management guided by the respiratory variation of the internal jugular vein during abdominal surgeries can reduce postoperative complications. The patients will be divided into two groups and randomized to receive either intraoperative fluid therapy guided by the respiratory variation of the internal jugular vein or standard fluid therapy. Postoperative complications, length of hospital stay, total amount of fluid administered intraoperatively, use of vasopressors in both groups, and incidence of hypotensive episodes will be recorded.

Conditions

Postoperative Complications

Keywords

Postoperative Complications; Abdominal surgeries; Internal Jugular Vein; Intraoperative fluid therapy

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the incidence of postoperative complications in both groups, which will be measured by the occurrence of any of the postoperative complications during the first seven postoperative days in both groups

  Postoperative complications will include: (i) infections (urinary tract infection, wound infection, sepsis/septic shock) (ii) GI (Ileus, acute bowel obstruction, GI bleeding, abdominal compartment syndrome), (iii) Cardiovascular (deep venous thrombosis, pulmonary embolism, myocardial ischemia or infarction, cardiac arrest), (iv) Renal (AKI) (v) Respiratory (pneumonia, prolonged mechanical ventilation (more than 24 hours), respiratory failure, ARDS).

  The first seven postoperative days

Secondary Outcomes (4)

• The length of hospital stay in both groups

  Up to 30 days postoperatively.

• Assessment of the total amount of fluid administered intraoperatively in both groups

  Intraoperatively (From the start to the end of the surgery)

• Intraoperative vasopressor use in both groups

  Intraoperatively (From the start to the end of the surgery)

• Intraoperative hypotensive episodes in both groups

  Intraoperatively (From the start to the end of the surgery)

Study Arms (2)

Internal Jugular Vein (IJV) group (Study group)

ACTIVE COMPARATOR

In this group, fluid therapy will be guided by the respiratory variation of IJV throughout the surgery.

Diagnostic Test: Respiratory variation of the Internal Jugular Vein (IJV)

Control group

NO INTERVENTION

In this group, conventional fluid therapy will be given to ensure that the mean arterial blood pressure is equal to or more than 65 mmHg.

Interventions

Respiratory variation of the Internal Jugular Vein (IJV) DIAGNOSTIC_TEST

In the study group, the fluid therapy will be guided by the respiratory variation (RV) of the Internal Jugular Vein (IJV) throughout surgery. Fluid maintenance will be continued as long as the IJV diameter is less than 2 cm and the IJV RV is more than 18. If the IJV diameter exceeds 2 cm and the IJV RV is less than 18, fluids will be stopped.

Internal Jugular Vein (IJV) group (Study group)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients' American Society of Anesthesiologists physical status (ASA) is I and II.
• The target age group is 20 to 70 years old.
• Patients scheduled for abdominal surgery under general anesthesia with normal renal function.

You may not qualify if:

• Refusal of the procedure or participation in the study.
• Coagulopathy.
• Pre-existing cardiac, renal, and respiratory diseases. 4-Internal jugular vein thrombosis

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (2)

Suez Canal University Hospitals

Ismailia, Ismailia Governorate, 41522, Egypt

NOT YET RECRUITING

Suez Canal University Hospitals

Ismailia, Egypt

RECRUITING

Related Publications (8)

• Sanfilippo F, La Via L, Dezio V, Santonocito C, Amelio P, Genoese G, Astuto M, Noto A. Assessment of the inferior vena cava collapsibility from subcostal and trans-hepatic imaging using both M-mode or artificial intelligence: a prospective study on healthy volunteers. Intensive Care Med Exp. 2023 Apr 3;11(1):15. doi: 10.1186/s40635-023-00505-7.

  PMID: 37009935 BACKGROUND

• Miller TE, Mythen M, Shaw AD, Hwang S, Shenoy AV, Bershad M, Hunley C. Association between perioperative fluid management and patient outcomes: a multicentre retrospective study. Br J Anaesth. 2021 Mar;126(3):720-729. doi: 10.1016/j.bja.2020.10.031. Epub 2020 Dec 13.

  PMID: 33317803 BACKGROUND

• Ma GG, Hao GW, Yang XM, Zhu DM, Liu L, Liu H, Tu GW, Luo Z. Internal jugular vein variability predicts fluid responsiveness in cardiac surgical patients with mechanical ventilation. Ann Intensive Care. 2018 Jan 16;8(1):6. doi: 10.1186/s13613-017-0347-5.

  PMID: 29340792 BACKGROUND

• Kan CFK, Skaggs JD. Current Commonly Used Dynamic Parameters and Monitoring Systems for Perioperative Goal-Directed Fluid Therapy: A Review. Yale J Biol Med. 2023 Mar 31;96(1):107-123. doi: 10.59249/JOAP6662. eCollection 2023 Mar.

  PMID: 37009197 BACKGROUND

• Deslarzes P, Jurt J, Larson DW, Blanc C, Hubner M, Grass F. Perioperative Fluid Management in Colorectal Surgery: Institutional Approach to Standardized Practice. J Clin Med. 2024 Jan 30;13(3):801. doi: 10.3390/jcm13030801.

  PMID: 38337495 BACKGROUND

• Dai S, Shen J, Tao X, Chen X, Xu L. Can ultrasonographic measurement of respiratory variability in the diameter of the internal jugular vein and the subclavian vein predict fluid responsiveness in parturients during cesarean delivery? A prospective cohort study. Heliyon. 2022 Dec 13;8(12):e12184. doi: 10.1016/j.heliyon.2022.e12184. eCollection 2022 Dec.

  PMID: 36536919 BACKGROUND

• Kang D, Yoo KY. Fluid management in perioperative and critically ill patients. Acute Crit Care. 2019 Nov;34(4):235-245. doi: 10.4266/acc.2019.00717. Epub 2019 Nov 29.

  PMID: 31795621 BACKGROUND

• Aaen AA, Voldby AW, Storm N, Kildsig J, Hansen EG, Zimmermann-Nielsen E, Jensen KM, Tibaek P, Mortensen A, Moller AM, Brandstrup B. Goal-directed fluid therapy in emergency abdominal surgery: a randomised multicentre trial. Br J Anaesth. 2021 Oct;127(4):521-531. doi: 10.1016/j.bja.2021.06.031. Epub 2021 Aug 11.

  PMID: 34389168 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammad E Salama, MD

  Suez canal university hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad E Salama, MD

CONTACT

00201016865861; MohammadElhossieny88@med.suez.edu.eg

Adel A Hassan, MD

CONTACT

00201007921234; adel.hassan@med.psu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 27, 2025
• Study Start: July 15, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-06

Locations

EG (2)