the Effects of Perioperative Goal Directed and Conventional Fluid Management on the IVC Collapsibility Index

NCT05154435 | Completed

• 1 other identifier: FSMTRH1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aimed to compare the effects of targeted fluid management and traditional fluid management on the inferior vena cava collapsibility index in participants who will undergo proximal femoral surgery. In addition, the amount of fluid given, blood products, the number of perioperative hypotensive events, perioperative hemodynamics, perioperative and postoperative blood gas analysis, perioperative urine output and bleeding amount, postoperative complications (cardiac, respiratory, renal, etc.), postoperative 30-day mortality, nausea and vomiting score, It was aimed to evaluate and compare the postoperative hospitalization day as secondary.

Conditions

Femoral Neck Fractures

Keywords

intraoperative care, hemodynamic monitoring, fluid therapy

Outcome Measures

Primary Outcomes (1)

• Inferior vena cava (IVC) collapsibility index

  inspiratory IVC diameter and expiratory IVC diameter will measured and collapsibility index will be calculated

  one month

Secondary Outcomes (4)

• amount of given crystalloid and colloid volume

  one month

• arterial blood gas analysis

  one month

• postoperative complications (yes or no)

  one month

• postoperative 30-day mortality (yes or no)

  one month

Study Arms (2)

Grup HYT

ACTIVE COMPARATOR

The group (GRUP HYT) to be treated with targeted fluid therapy will be monitored with a Mostcaretm (Vygon, VytechHealth, Padova, Italy) pulse contour hemodynamic monitor after arterial cannulation. Cardiacindex (CI), stroke volume variance (SVV), pulse pressure variance (PPV), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), oxygen delivery (Do2), arterial elastance (Ea) measurements and mean arterial pressure Every 5 minutes to be followed, fluid therapy will be planned in accordance with our algorithm.

Drug: mostcare hemodynamic monitor

Grup KON

NO INTERVENTION

Fluid deficit due to fasting time will be calculated in accordance with the 4-2-1 rule for patients in Group KON. half of the calculated fluid volume in the first hour; the remaining half will be given at the 2nd and 3rd Hours. (4ml/kg/hr for the first 10 kilograms, 2ml/kg/hr for the second 10 kg, 1ml/kg/hr for each subsequent kilogram). Maintenance fluid will be considered as a medium-sized surgical trauma and will be given at 4 ml/kg/hr. Hemorrhages will be replaced with 3 times the blood loss with balanced crystalloid or 1 times HES.

Interventions

mostcare hemodynamic monitor DRUG

mostcare hemodynamic monitoring integrated into the radial artery catheter. According to the data obtained, intraoperative fluid management was arranged with certain algorithms.

Also known as: minimally invasive cardiac output monitors

Grup HYT

Eligibility Criteria

• Age: 65 Years - 101 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years and older
• ASA anesthesia risk
• Planned to undergo proximal femoral surgery due to intertochanteric fracture

You may not qualify if:

• cardiac arrhythmia,
• chronic renal failure and those on dialysis,
• heart failure,
• aortic insufficiency,
• active lower/upper respiratory tract infections,
• inferior vena cava cannot be clearly visualized by USG, BMI\>35, Patients in need of postoperative intensive care or ASA4, Patients with advanced obstructive or restrictive respiratory diseases, Patients under 65 years of age.

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Research and Training Hospital

Istanbul, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• arzu yıldırım ar, ass prof

  Fatih Sultan Mehmet Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The patients who accepted to participate in the study and the doctor who measured the inferior vena cava did not know the groups of the patients.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 60 patients over the age of 65, who were scheduled for proximal femoral surgery due to intertochanteric fracture, and operated with ASA1-3 risk will be included in the study. The patients will be randomized into two groups as Group K (n=30) and Group H (n=30) by the closed envelope method and the patients will not know their groups.

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 13, 2021
• Study Start: July 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 15, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)