Pulse Pressure Variation Vs. Central Venous Pressure for Fluid Management in Intracranial Tumor Surgery

NCT06776666 | Completed

• 2 other identifiers: E-60116787-020-512899ET-GD-CVP-PPV-FLD-001
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the efficacy of pulse pressure variation (PPV) compared to central venous pressure (CVP) in guiding fluid management during intracranial tumor surgeries. Perioperative fluid therapy is critical to prevent complications arising from both hypovolemia (e.g., hypotension, tissue hypoperfusion, ischemia) and hypervolemia (e.g., pulmonary edema, delayed wound healing, infection). Traditional fluid therapy relies on static parameters such as CVP, which have limited sensitivity and specificity. Emerging technologies and dynamic parameters, including PPV and stroke volume variation (SVV), offer higher accuracy in evaluating fluid responsiveness. This randomized study includes 42 patients, aged 18-65 years, undergoing elective intracranial tumor surgery under general anesthesia. Patients are classified as ASA I-III and are randomized into two groups:

1. 1.Group N: Fluid therapy guided by PPV.
2. 2.Group S: Fluid therapy guided by CVP. The study follows standard perioperative protocols, with PPV (\>13%) and CVP (0-6 mmHg) used as primary parameters for fluid administration. Key outcomes include intraoperative fluid requirements (primary) and secondary parameters such as serum lactate levels, incidence of hypotension, brain relaxation scores, and ICU length of stay.

Conditions

Brain Tumor Adult; Pulse Pressure Variation; Central Venous Pressure; Fluid Management; Brain Surgery

Keywords

Central venous pressure; Fluid management; Brain tumors; Pulse pressure variation; Surgery

Outcome Measures

Primary Outcomes (1)

• Fluid requirement (number of times needing bolus infusion-during surgery)

  Fluid requirement (number of times needing bolus infusion) One bolus infusion 250 mL amount Bolus fluid requirement will be assessed every 15 minutes throughout the operation. Assesment will make two method: CVP and PPV. Will be to compare the intraoperative fluid requirement between the two groups. 1. CVP (Central Venous Pressure) group: In cases where CVP\<6 mmHg during the intraoperative period, patients will be given an additional 250 ml bolus crystalloid infusion over a 10 minute period and LVB will be re-evaluated. 2. PPV (Pulse Pressure Variation) group: In cases where the pulse pressure variations value is \>13%, patients will be given an additional 250 ml of crystalloid fluid over a 10 minute period and pulse pressure variations will be reassessed.

  At 10-minutes intervals throughout the surgery

Secondary Outcomes (1)

• Duration of postoperative stay in the intensive care unit

  in 2 weeks

Other Outcomes (3)

• Intraoperative and postoperative creatinine value

  Beginning of surgery, end of surgery and postoperative 24. hour creatinine value

• Intraoperative and postoperative serum lactate value

  Beginning of the surgery, end of the surgery and postoperative 24. hour lactate value

• Brain relaxation scores

  Within 5 minutes after surgical removal of the dura mater during surgery

Study Arms (2)

PPV

Patients with intraoperative fluid management according to PPV parameters

CVP

patients with intraoperative fluid management according to CVP parameters

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* ages of 18-65 * ASA (American Society of Anesthesiology) physical status classification score I-III * who will undergo elective intracranial mass surgery under general anesthesia

You may qualify if:

• ages of 18-65
• ASA (American Society of Anesthesiology) physical status classification score I-III
• who will undergo elective intracranial mass surgery under general anesthesia

You may not qualify if:

• Patients with renal failure
• mental retardation
• arrhythmia
• severe cardiopulmonary disease
• hemodynamic instability
• body mass index (BMI) \>40 kg/m2
• respiratory system compliance (Crs) \<30 mL/cmH2O
• use of lactate-producing drugs such as metformin
• lactate elevation at the beginning of the operation
• tumor causing diabetes insipitus
• patients who do not accept the procedure

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, 20020, Turkey (Türkiye)

Location

Related Publications (19)

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MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 15, 2025
• Study Start: April 3, 2024
• Primary Completion: December 5, 2024
• Study Completion: December 15, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

TU (1)