PoCUS Guided Fluids to Prevent Post-induction Hypotension

NCT05424510 | Completed

• 1 other identifier: 22-0043-A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Hypotension is a common side-effect of general anesthesia induction, and is related to adverse outcomes, including a significantly increased risk of one-year mortality. Hypovolemia is a significant risk factor, and optimized fluid therapy remains the cornerstone of its treatment. Ultrasound measurements of inferior vena cava (IVC) diameter with respiration have been recommended as rapid and noninvasive methods for estimating volume status. Several recent studies reported that preoperative IVC ultrasound has a reliable predicting ability of arterial hypotension after the induction of general anesthesia. The practical effect of optimizing fluid status before surgery using this ability has not been studied. Our hypothesis is that preoperative ultrasound-guided intravenous fluid bolus administration may reduce the incidence of hypotension after the induction of general anesthesia in adults presenting for elective non-cardiac, non-obstetric surgery

Conditions

Hypotension on Induction

Keywords

point of care ultrasound; general anesthesia

Outcome Measures

Primary Outcomes (1)

• Difference in the incidence of hypotension after induction of general anesthesia

  hypotension as MAP below an absolute threshold of 65 mmhg or relative threshold of 25% decrease from baseline, or the administration of vasopressors during the induction period

  20 minutes from the induction of general anesthesia

Secondary Outcomes (3)

• The incidence of surgical delays

  Patient consent until the beginning of the operation

• The duration of post-induction hypotension

  20 minutes after induction

• Adverse events

  20 minutes after induction

Study Arms (2)

Fluid Bolus (FB+)

ACTIVE COMPARATOR

Patients in the FB+ group will receive a single bolus of 500 ml of Ringer's Lactate over 5-10 minutes.

Drug: Ringer's Lactate; Other: IV line

Non fluid bolus (FB-)

PLACEBO COMPARATOR

Patients in the FB- group will not receive a fluid bolus.

Other: IV line

Interventions

Ringer's Lactate DRUG

500 ml of Ringer's Lactate

Fluid Bolus (FB+)

IV line OTHER

Placing of an IV line before surgery

Fluid Bolus (FB+); Non fluid bolus (FB-)

Eligibility Criteria

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

You may qualify if:

• Age 18-70 years
• Elective surgery
• IVC-CI ≥ 43% on their preoperative POCUS scan.

You may not qualify if:

• Hypotension, defined as MAP below 65 mmhg, prior to the induction of general anesthesia.
• Treated with angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARB) on the day of surgery.
• Patients with heart failure with ejection fraction (EF) \< 40%.
• Patients with documented acute or chronic renal failure.
• Patients with neuraxial blockade (epidural or spinal) performed before induction of general anesthesia.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (1)

• Dana E, Arzola C, Khan JS. Prevention of hypotension after induction of general anesthesia using point-of-care ultrasound to guide fluid management: a randomized controlled trial. Can J Anaesth. 2024 Sep;71(9):1219-1228. doi: 10.1007/s12630-024-02748-8. Epub 2024 Mar 13.

  PMID: 38480632 DERIVED

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• James S Khan, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: In all fluid responsive patients an IV line will be placed, regardless of group allocation into FB+ or FB-. In order to maintain masking of the treating anesthesiologist, patients will be advised regarding the importance to not disclose whether they received a fluid bolus or not to their anesthetist.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pain Physician and Anesthesiologist

Model Details: Based on the IVC PoCUS exam, volume responsive patients will be randomized into two equal groups: half will receive a fluid bolus (FB+) and half will not (FB-). Patients in the FB+ group will receive a single bolus of 500 ml of Ringer's Lactate over 5-10 minutes with an additional IVC scan at the end of the infusion to record the change in IVC-CI.

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: July 5, 2022
• Primary Completion: February 22, 2023
• Study Completion: February 22, 2023
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)