Trial Outcomes & Findings for Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery (NCT NCT02638623)

Results Overview

Patients found to have a 90-day postoperative complication categorized as Infection, CHF/Fluid overload, MI, DVT/PE, other

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

52 participants

Primary outcome timeframe

90 days post surgery

Results posted on

2020-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Lactated Ringer Bolus Group Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement Lactated Ringer: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty	Placebo Covered empty bag with no hydration supplement Placebo: No additional fluids will be administered
Overall Study STARTED	27	25
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Lactated Ringer Bolus Group Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement Lactated Ringer: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty	Placebo Covered empty bag with no hydration supplement Placebo: No additional fluids will be administered
Overall Study Surgery timing	5	6
Overall Study Not given intervention	2	0

Baseline Characteristics

52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lactated Ringer Bolus Group n=20 Participants Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement Lactated Ringer: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty	Placebo n=19 Participants Covered empty bag with no hydration supplement Placebo: No additional fluids will be administered	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.	0 Participants n=7 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.	0 Participants n=5 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.	14 Participants n=7 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.	33 Participants n=5 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.
Age, Categorical >=65 years	1 Participants n=5 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.	5 Participants n=7 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.	6 Participants n=5 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.
Sex: Female, Male Female	12 Participants n=5 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.	5 Participants n=7 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.	17 Participants n=5 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.
Sex: Female, Male Male	8 Participants n=5 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.	14 Participants n=7 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.	22 Participants n=5 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.
Region of Enrollment United States	20 participants n=5 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.	19 participants n=7 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.	39 participants n=5 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.
Surgical Procedure Hip Replacement	4 Participants n=5 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.	11 Participants n=7 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.	15 Participants n=5 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.
Surgical Procedure Knee Replacement	16 Participants n=5 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.	8 Participants n=7 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.	24 Participants n=5 Participants • 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs.

PRIMARY outcome

Timeframe: 90 days post surgery

Population: Chart review for patients up to 90 days after surgery documenting the above complications.

Patients found to have a 90-day postoperative complication categorized as Infection, CHF/Fluid overload, MI, DVT/PE, other

Outcome measures

Outcome measures
Measure	Lactated Ringer Bolus Group n=20 Participants Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement Lactated Ringer: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty	Placebo n=19 Participants Covered empty bag with no hydration supplement Placebo: No additional fluids will be administered
Number of Participants With Postoperative Complications Wound Infection	0 participants	1 participants
Number of Participants With Postoperative Complications DVT/PE	0 participants	0 participants
Number of Participants With Postoperative Complications MI	0 participants	0 participants
Number of Participants With Postoperative Complications CHF/Fluid Overload	0 participants	0 participants
Number of Participants With Postoperative Complications Other	2 participants	0 participants

SECONDARY outcome

Timeframe: 90 days postop

Patient readmitted to the hospital 90 day postoperatively

Outcome measures

Outcome measures
Measure	Lactated Ringer Bolus Group n=20 Participants Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement Lactated Ringer: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty	Placebo n=19 Participants Covered empty bag with no hydration supplement Placebo: No additional fluids will be administered
90 Day Readmission Count Readmission	0 Participants	1 Participants
90 Day Readmission Count No Readmission	20 Participants	18 Participants

SECONDARY outcome

Timeframe: Surgery to hospital discharge

Hours of Hospital Stay

Outcome measures

Outcome measures
Measure	Lactated Ringer Bolus Group n=20 Participants Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement Lactated Ringer: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty	Placebo n=19 Participants Covered empty bag with no hydration supplement Placebo: No additional fluids will be administered
Duration of Hospital Stay (Hours)	53.86 hours Interval 26.0 to 169.0	36.13 hours Interval 24.0 to 78.0

SECONDARY outcome

Timeframe: Incision to end of surgery

Minutes recorded for length of surgery

Outcome measures

Outcome measures
Measure	Lactated Ringer Bolus Group n=20 Participants Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement Lactated Ringer: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty	Placebo n=19 Participants Covered empty bag with no hydration supplement Placebo: No additional fluids will be administered
Duration of Surgery	122.68 Minutes Interval 87.0 to 172.0	126.3 Minutes Interval 102.0 to 158.0

SECONDARY outcome

Timeframe: Hospital Stay

Number of recorded emesis episodes in the medical record while patient was hospitalized

Outcome measures

Outcome measures
Measure	Lactated Ringer Bolus Group n=20 Participants Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement Lactated Ringer: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty	Placebo n=19 Participants Covered empty bag with no hydration supplement Placebo: No additional fluids will be administered
Emesis Episodes	0.26 emesis episodes Interval 0.0 to 2.0	0.11 emesis episodes Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: surgical period

milliliters of fluid administered during surgery

Outcome measures

Outcome measures
Measure	Lactated Ringer Bolus Group n=20 Participants Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement Lactated Ringer: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty	Placebo n=19 Participants Covered empty bag with no hydration supplement Placebo: No additional fluids will be administered
Volume of Fluid Administred	1635 milliliters Interval 400.0 to 4750.0	1518 milliliters Interval 700.0 to 2600.0

Adverse Events

Lactated Ringer Bolus Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Matthew J. Dietz, MD

West Virginia University Department of Orthopaedics

Phone: 304-285-7445

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place