Trial Outcomes & Findings for The Effect of Hypotensive Anesthesia on Hemoglobin Levels During Total Knee Arthroplasty (NCT NCT05340751)

NCT ID: NCT05340751

Last Updated: 2023-01-26

Results Overview

To investigate the effect of intraoperative fluid substitution during HEA on hemoglobin levels during and after primary TKA.

• Recruitment status: COMPLETED
• Target enrollment: 35 participants
• Primary outcome timeframe: up to 48 hours after surgery
• Results posted on: 2023-01-26

Participant Flow

Participant milestones

Measure	Anesthesia hemoglobin Blood drawn: Hemoglobin and Hematocrit Levels
Overall Study STARTED	35
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Anesthesia hemoglobin Blood drawn: Hemoglobin and Hematocrit Levels
Overall Study Physician Decision	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Anesthesia n=32 Participants hemoglobin Blood drawn: Hemoglobin and Hematocrit Levels
Age, Continuous	66 years n=32 Participants
Sex: Female, Male Female	22 Participants n=32 Participants
Sex: Female, Male Male	10 Participants n=32 Participants

PRIMARY outcome

Timeframe: up to 48 hours after surgery

To investigate the effect of intraoperative fluid substitution during HEA on hemoglobin levels during and after primary TKA.

Outcome measures

Measure	Anesthesia n=32 Participants hemoglobin Blood drawn: Hemoglobin and Hematocrit Levels
The Hemoglobin (in g/dl) Levels 15 min	12.2 g/dl Standard Deviation 1.2
The Hemoglobin (in g/dl) Levels 30 min	12.0 g/dl Standard Deviation 1.2
The Hemoglobin (in g/dl) Levels 45 min	11.9 g/dl Standard Deviation 1.595
The Hemoglobin (in g/dl) Levels 60 min	11.8 g/dl Standard Deviation 1.3
The Hemoglobin (in g/dl) Levels PACU stay	12.0 g/dl Standard Deviation 1
The Hemoglobin (in g/dl) Levels POD1 (24hr)	11.6 g/dl Standard Deviation 1.2
The Hemoglobin (in g/dl) Levels POD2 (48hr)	11.0 g/dl Standard Deviation 1.3

PRIMARY outcome

Timeframe: Up to 48 hours after surgery

To Investigates the effect of intraoperative fluid substitution during HEA on hematocrit levels during and after primary TKA.

Outcome measures

Measure	Anesthesia n=32 Participants hemoglobin Blood drawn: Hemoglobin and Hematocrit Levels
Hematocrit (g/dL) Levels POD (48hr)	32.6 g/dl Standard Deviation 3.2
Hematocrit (g/dL) Levels 15 min	36.8 g/dl Standard Deviation 3.2
Hematocrit (g/dL) Levels 30 min	36 g/dl Standard Deviation 3.1
Hematocrit (g/dL) Levels 45 min	35.4 g/dl Standard Deviation 2.9
Hematocrit (g/dL) Levels 60 min	34.7 g/dl Standard Deviation 3.1
Hematocrit (g/dL) Levels PACU	35.1 g/dl Standard Deviation 2.7
Hematocrit (g/dL) Levels POD1 (24hr)	35.3 g/dl Standard Deviation 3.4

Adverse Events

Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Friedrich Boettner

Hospital for Special Surgery

Phone: 2127742127

Email: BoettnerF@hss.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place