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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06133257
Enrollment
52
Registered
2023-11-15
Start date
2023-12-01
Completion date
2024-08-01
Last updated
2023-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, ERAS, Fluid Overload, Hypovolemia; Surgical Shock

Brief summary

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

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.

Interventions

PROCEDUREGoal-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.

standard fluid management

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Post Anesthesia Care Unit(PACU) Stay2 hours postoperativelytime spent in PACU after surgery measured in minutes
Mean Arterial Blood Pressureintraoperatively every 5 minutesintraoperative mean arterial blood pressure measured in mmHg
Quality of Recovery-40 score(QoR-40)24 hours postoperativeQoR-40 score ranges from 40 to 200, the higher the score the better the outcome
Heart Rateintraoperatively every 5 minutesintraoperative heart rate will be continuously monitored and recorded every 5 minutes

Secondary

MeasureTime frameDescription
Total fluid intake during operationintraoperativelyTotal fluid intake during operation
Number of patients that needed Ephedrine or AtropineintraoperativelyNumber of patients that needed Ephedrine or Atropine intraoperatively
Peripheral perfusion indexIntraoperativelyPeripheral 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.
Length of hospital staythe patient will be followed up for 60 days from day of surgerythe number of days from day of surgery until patient's discharge from hospital

Contacts

Primary ContactMahmoud Abdelkader, MBBCh
mahmoud.ab.ali@gmail.com00201553638376
Backup ContactAlshaimaa Kamel, MD.
AlshaimaaKamel80@yahoo.com01005593169

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026