Goal-Directed Fluid Therapy in Patients Undergoing Lower Limb Surgeries

Effects of Goal-Directed Fluid Therapy Guided by Inferior Vena Cava Collapsibility Index on Hemodynamics and Enhanced Recovery in Patients Undergoing Lower Limb Surgeries

Controlling the amount of fluids given to patients in perioperative setting can significantly influence their outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia; Fluid Overload; ERAS; Hypovolemia; Surgical Shock
• Intervention / Treatment: Procedure: Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility Index; Procedure: standard fluid management

Detailed Description

To overcome these problems and avoid the complications of over or underhydration, we use the Goal-directed fluid therapy(GDFT) guided by Inferior vena cava(IVC) collapsibility index approach in which dynamic parameters of volume responsiveness as a guide for fluid therapy. This will ensure that the fluids given were deficient from the circulation and improve the recovery of the patients according to enhanced recovery after surgery(ERAS) protocols.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alshaimaa Kamel, MD.; Phone Number: 002 01005593169; Email: AlshaimaaKamel80@yahoo.com
• Study Contact Backup: Name: Mahmoud Abdelkader, MBBCh; Phone Number: 00201553638376; Email: mahmoud.ab.ali@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patient's acceptance.
• Patients planned for elective lower limb surgery under spinal anesthesia.
• Both sexes
• Body Mass Index(BMI): <35
• Age: 21 ~ 65 years
• American Society of Anesthesiologists(ASA) Physical Status Classification System: Class I & II
• Duration of surgery 2~3 hours

Exclusion Criteria:

• Advanced kidney, liver, respiratory or cardiovascular disease.
• Contraindication for spinal anesthesia.
• Patients shifted to general anesthesia for any reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GD Group; Patients will take oral clear fluids with carbohydrates content 2 hours preoperatively and intraoperative fluid intake will be guided by Inferior vena cava(IVC) diameter.	Procedure: Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility Index; Measuring Inferior vena cava(IVC) diameter using ultrasound then calculation Inferior vena cava(IVC) collapsibility index and administer fluid accordingly.
Active Comparator: C Group; the standard fluid management group patients will be fasting 6 hours preoperatively and will receive intraoperative fluid in standard manner.	Procedure: standard fluid management; standard fluid management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Arterial Blood Pressure	intraoperative mean arterial blood pressure measured in mmHg	intraoperatively every 5 minutes
Quality of Recovery-40 score(QoR-40)	QoR-40 score ranges from 40 to 200, the higher the score the better the outcome	24 hours postoperative
Heart Rate	intraoperative heart rate will be continuously monitored and recorded every 5 minutes	intraoperatively every 5 minutes
Post Anesthesia Care Unit(PACU) Stay	time spent in PACU after surgery measured in minutes	2 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total fluid intake during operation	Total fluid intake during operation	intraoperatively
Number of patients that needed Ephedrine or Atropine	Number of patients that needed Ephedrine or Atropine intraoperatively	intraoperatively
Peripheral perfusion index	Peripheral Perfusion Index (PPI) is defined as "the ratio of pulsatile blood flow to the non-pulsatile blood flow". It ranges from 0.02% to 20% and it is measured using specific types pulse oximetry and it reflects the perfusion status of the body.	Intraoperatively
Length of hospital stay	the number of days from day of surgery until patient's discharge from hospital	the patient will be followed up for 60 days from day of surgery

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Mahmoud Abdelkader, MBBCh, Anesthesia, Intensive Care and Pain Management department, Faculty of Medicine, Zagazig University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Shock; Hypovolemia; Shock, Surgical
• Other Study ID Numbers: 11122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No