Arthroplasty, Replacement, KneeNCT03719378
Traditional vs Oral Fluid Management in Total Knee Arthroplasty
A study testing Pre Operative Oral Fluids in people with Arthroplasty, Replacement, Knee, run by Colorado Joint Replacement at 1 site in United States.
Trial summary
Purpose: Evidence-based guidelines on optimal perioperative fluid management have not been established in patients undergoing orthopaedic surgery. Recent randomized trials in major abdominal surgery suggest that large amounts of IV fluid may increase morbidity and hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Pre Operative Oral Fluids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2015to 10 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18-75 years old undergoing a primary total knee arthroplasty for a diagnosis of degenerative osteoarthritis who do not meet the exclusion criteria listed below
Who cannot join
- Volume-dependent cardiac conditions:
- Aortic stenosis
- Pulmonary valve stenosis
- Subaortic stenosis
- Severe Aortic Insufficiency
- Chronic systolic heart failure
Show all 20Show fewer
- Eisenmeinger Syndrome
- Severe pulmonary HTN
- Chronic or paroxysmal dysrhythmias
- Pre-operative electrolyte abnormalities
- Abnormalities of the HPA (hypothalamic-pituitary axis)
- Stage 3 Chronic Kidney Disease (or worse)
- Patients taking angiotensin receptor blockers (ARB)
- Patients with uncontrolled diabetes mellitus (patient with A1C of 7+ or on insulin)
- Patients whose BMI is > 35 38 or < 19
- Current use of long acting narcotic medication or 3 or more months of daily short acting narcotic medication
- Patients at risk for electrolyte abnormalities, dehydration or intra-operative hypotension. (patients taking angiotensin receptor blockers, ACE inhibitors (48 hours prior to surgery) and Diuretics)
- Patients with severe, untreated or uncontrolled GERD.
- Patients that cannot receive spinal anesthesia (e.g. patient with back fusions)
- Pre-Operative Anemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Traditional Intravenous Versus Oral Fluid Management in Total Knee Arthroplasty
Purpose: Evidence-based guidelines on optimal perioperative fluid management have not been established in patients undergoing orthopaedic surgery. Recent randomized trials in major abdominal surgery suggest that large amounts of IV fluid may increase morbidity and hospital stay. This study will investigate the effects of two regimens of intraoperative fluid management ("traditional" vs. "oral") with physiologic and patient function as primary outcome measures after surgery.
Read the detailed description
Evidence-based guidelines on optimal perioperative fluid management have not been established in patients undergoing orthopaedic surgery. Typical intraoperative and post-operative fluid management has been arbitrary without evidence based guidelines established following total joint replacement. The investigators have observed many patients post-operatively with side effects such as fluid overload leading to medical complications requiring either prolonged hospitalization or readmission. Additionally, this overload may lead to wound healing complications secondary to fluid shifts which may be devastating in this patient population. Recent randomized trials in major abdominal surgery suggest that large amounts of IV fluid may increase morbidity and hospital stay. Additionally, this increase fluid may be detrimental in patients with anastomosis leading to failure and/or complications in this patient population. The investigators have defined to specific groups of interest to study in this patient population with regards to fluid management. The first group is the "traditional" IV fluid group where the anesthesiologist gives an unspecific amount of fluid intraoperatively and post-operatively the patient gets a set amount of fluid based on "protocol" on the orthopaedic floor (i.e. 75 cc/hour until good oral intake). This is the protocol utilized by most orthopaedic practices throughout the United States. The second group is defined as patients who are given a specific protocol preoperatively to optimize hydration, followed by limited fluids intraoperatively based on physiologic parameters. This study will investigate the effects of two regimens of intraoperative fluid management ("traditional" vs. "oral") with
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Pre Operative Oral Fluids
- Keywords
- Fluid Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre Operative Oral FluidsOther
Patients will be self hydrating prior to their total knee replacement.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Fluid | No intervention | * NPO Clears and Food after midnight. * 2 Liters of lactated ringers administered by anesthesia intraoperatively. * Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). * Normal diet postoperatively. |
| Oral Fluid | Experimental | * Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.)
* NPO Food/Milk: none beginning 8 hours prior to procedure time.
* Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.)
* Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total.
* PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Receives: Other: Pre Operative Oral Fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Patient Weight will be monitored
Measured: Change is patients weight from baseline at pre op to two weeks post op.
Secondary outcomes (17)
Knee Range of Motion
Measurements will be done with a standard goniometer (Measurements below are shown as the difference from their pre operative base line measurement to the time points below)
Measured: Post Op Day 1, 2 Weeks and 6 Weeks Post Op
Leg Anthropometric (Girth) Measurements
measurements will be performed at 5 \& 10 cm suprapatellar, midpatella, and 10 cm infrapatellar with the use of a standard tape measure. measurements below show the difference from their pre operative base line measurement to the timepoints below.
Measured: Post op Day 1, 2 weeks and 6 weeks Post Op
Number of Participants With Requiring Transfusions
Post Operative/Intra Operative Transfusions
Measured: intra operative, Post Op Day #1 or #2
Number of Participants With Off Wound Complications Post Operative
incidence of wound infection and wound drainage will be assessed and recorded
Measured: Up to 6 weeks Post OP
Number of Participants With Thromboembolic Disease
The incidence of thromboembolic events will be recorded.
Measured: Post Opeartive until the 6 week follow up appointment
Quadriceps Strength Measure With a Handheld Dynamometer
The strength testing will be calculated using a handheld dynamometer
Measured: Post Op day 1, 2 Week and 6 Week Post OP
Time up and GO
timed up and go (TUG)
Measured: preoperative appointment and once again at their 2 and 6 weeks postoperatively
30 Second STS Test
30 second sit-to-stand tests
Measured: preoperative appointment and once again at their 2 and 6 weeks postoperatively
Length of the Hospitalization
Length of time the patient is Hospitalized after their total knee replacement.
Measured: Daily up to 2 days while hospitalized
Number of Patients Re-admitted Post TKA
Number of patients re-admitted post TKA
Measured: up to 6 weeks post op
Postoperative Pain Assessment Using Visual Analog Scale
Pain will be assessed using a pain Visual Analog scale(VAS), the scale is from 1 to 10, the higher the score the worse the pain.
Measured: Every 4 hours, averaged daily, reported at Post op day 1 and 2 (while in the hospital), weeks 1, 2, 3, and 4 (3 times a day)
PONV (Post-operative Nausea and Vomiting)
patients will be asked about Nausea: None, Mild, Moderate or Severe
Measured: Daily up to 2 days while hospitalized
Veterans Rand -12
Patient Reported Outcomes- Veterans Rand(VR-12), there is an algorithm to calculate this score, not a specific range. The higher the number the more positive the output. The score has two components a mental score (MCS) and Physical Score (PCS). Higher values represent a better outcome.
MCS Scale 35.089613 to 46.341715 PCS Scale 14.957554 to 63.235672
Measured: 2 week and 6 week follow up appointments
Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee injury and Osteoarthritis Outcome Score (KOOS), the scale is 0 to 100, 100 being the best score possible.
Measured: pre-operatively as well as at their 2 week and 6 week follow up appointments
Patient Reported Outcomes - Knee Society Score(KSS)
Knee Society Score(KSS), the total scores range from 0 - 200, 200 being the best.
Measured: pre-operatively as well as at their 2 week and 6 week follow up appointments
Total IV Fluids Received
Total amount of IV fluids that the patients received while in the hospital
Measured: Duration of IV intervention, up to 2 days
Bioimpedence
body composition before and after surgery to measure swelling. Lower numbers represent more swelling.
Measured: pre-op visit, Post Op Day #1 as well as their 2 week and 6 week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start13 Oct 2015
- Primary completion10 Sep 2018
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado Joint Replacement
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Jennings, Colorado Joint Replacement
- Investigators
- Jason Jennings, MD, Principal investigator, Colorado Joint Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719378
- Sponsor's protocol ID
- 1060593
- Status last verified
- Feb 2021
- First submitted
- 6 Sep 2017
- Last updated
- 16 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marjanovic G, Villain C, Juettner E, zur Hausen A, Hoeppner J, Hopt UT, Drognitz O, Obermaier R. Impact of different crystalloid volume regimes on intestinal anastomotic stability. Ann Surg. 2009 Feb;249(2):181-5. doi: 10.1097/SLA.0b013e31818b73dc.
PubMed 19212167Marjanovic G, Villain C, Timme S, zur Hausen A, Hoeppner J, Makowiec F, Holzner P, Hopt UT, Obermaier R. Colloid vs. crystalloid infusions in gastrointestinal surgery and their different impact on the healing of intestinal anastomoses. Int J Colorectal Dis. 2010 Apr;25(4):491-8. doi: 10.1007/s00384-009-0854-4. Epub 2009 Nov 27.
PubMed 19943164Kulemann B, Timme S, Seifert G, Holzner PA, Glatz T, Sick O, Chikhladze S, Bronsert P, Hoeppner J, Werner M, Hopt UT, Marjanovic G. Intraoperative crystalloid overload leads to substantial inflammatory infiltration of intestinal anastomoses-a histomorphological analysis. Surgery. 2013 Sep;154(3):596-603. doi: 10.1016/j.surg.2013.04.010. Epub 2013 Jul 19.
PubMed 23876362
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Intravenous Versus Oral Fluid Management in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03719378
- Acronym / sponsor ID
- 1060593
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Fluid Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Colorado Joint ReplacementUniversity, hospital or other
- Study start
- 13 Oct 2015 (actual)
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Posted 16 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: Evidence-based guidelines on optimal perioperative fluid management have not been established in patients undergoing orthopaedic surgery. Recent randomized trials in major abdominal surgery suggest that large amounts of IV fluid may increase morbidity and hospital stay. This study will investigate the effects of two regimens of intraoperative fluid management ("traditional" vs. "oral") with physiologic and patient function as primary outcome measures after surgery.
Detailed description
Evidence-based guidelines on optimal perioperative fluid management have not been established in patients undergoing orthopaedic surgery. Typical intraoperative and post-operative fluid management has been arbitrary without evidence based guidelines established following total joint replacement. The investigators have observed many patients post-operatively with side effects such as fluid overload leading to medical complications requiring either prolonged hospitalization or readmission. Additionally, this overload may lead to wound healing complications secondary to fluid shifts which may be devastating in this patient population. Recent randomized trials in major abdominal surgery suggest that large amounts of IV fluid may increase morbidity and hospital stay. Additionally, this increase fluid may be detrimental in patients with anastomosis leading to failure and/or complications in this patient population. The investigators have defined to specific groups of interest to study in this patient population with regards to fluid management. The first group is the "traditional" IV fluid group where the anesthesiologist gives an unspecific amount of fluid intraoperatively and post-operatively the patient gets a set amount of fluid based on "protocol" on the orthopaedic floor (i.e. 75 cc/hour until good oral intake). This is the protocol utilized by most orthopaedic practices throughout the United States. The second group is defined as patients who are given a specific protocol preoperatively to optimize hydration, followed by limited fluids intraoperatively based on physiologic parameters. This study will investigate the effects of two regimens of intraoperative fluid management ("traditional" vs. "oral") with
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Fluid | No intervention | –* NPO Clears and Food after midnight. * 2 Liters of lactated ringers administered by anesthesia intraoperatively. * Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). * Normal diet postoperatively. |
| Oral Fluid | Experimental | Other: Pre Operative Oral Fluids* Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) * NPO Food/Milk: none beginning 8 hours prior to procedure time. * Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) * Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. * PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between the ages of 18-75 years old undergoing a primary total knee arthroplasty for a diagnosis of degenerative osteoarthritis who do not meet the exclusion criteria listed below
Key exclusion criteria (20 listed)
- Volume-dependent cardiac conditions:
- Aortic stenosis
- Pulmonary valve stenosis
- Subaortic stenosis
- Severe Aortic Insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre Operative Oral FluidsPatients will be self hydrating prior to their total knee replacement. | Other | Oral Fluid |
Primary outcome
Body Weight
Time frame: Change is patients weight from baseline at pre op to two weeks post op.
Patient Weight will be monitored
17 secondary outcomes
Knee Range of Motion
Time frame: Post Op Day 1, 2 Weeks and 6 Weeks Post Op
Leg Anthropometric (Girth) Measurements
Time frame: Post op Day 1, 2 weeks and 6 weeks Post Op
Number of Participants With Requiring Transfusions
Time frame: intra operative, Post Op Day #1 or #2
Number of Participants With Off Wound Complications Post Operative
Time frame: Up to 6 weeks Post OP
Number of Participants With Thromboembolic Disease
Time frame: Post Opeartive until the 6 week follow up appointment
Quadriceps Strength Measure With a Handheld Dynamometer
Time frame: Post Op day 1, 2 Week and 6 Week Post OP
Time up and GO
Time frame: preoperative appointment and once again at their 2 and 6 weeks postoperatively
30 Second STS Test
Time frame: preoperative appointment and once again at their 2 and 6 weeks postoperatively
Length of the Hospitalization
Time frame: Daily up to 2 days while hospitalized
Number of Patients Re-admitted Post TKA
Time frame: up to 6 weeks post op
Postoperative Pain Assessment Using Visual Analog Scale
Time frame: Every 4 hours, averaged daily, reported at Post op day 1 and 2 (while in the hospital), weeks 1, 2, 3, and 4 (3 times a day)
PONV (Post-operative Nausea and Vomiting)
Time frame: Daily up to 2 days while hospitalized
Veterans Rand -12
Time frame: 2 week and 6 week follow up appointments
Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: pre-operatively as well as at their 2 week and 6 week follow up appointments
Patient Reported Outcomes - Knee Society Score(KSS)
Time frame: pre-operatively as well as at their 2 week and 6 week follow up appointments
Total IV Fluids Received
Time frame: Duration of IV intervention, up to 2 days
Bioimpedence
Time frame: pre-op visit, Post Op Day #1 as well as their 2 week and 6 week visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19212167Marjanovic G, Villain C, Juettner E, zur Hausen A, Hoeppner J, Hopt UT, Drognitz O, Obermaier R. Impact of different crystalloid volume regimes on intestinal anastomotic stability. Ann Surg. 2009 Feb;249(2):181-5. doi: 10.1097/SLA.0b013e31818b73dc.
- Background: PubMed 19943164Marjanovic G, Villain C, Timme S, zur Hausen A, Hoeppner J, Makowiec F, Holzner P, Hopt UT, Obermaier R. Colloid vs. crystalloid infusions in gastrointestinal surgery and their different impact on the healing of intestinal anastomoses. Int J Colorectal Dis. 2010 Apr;25(4):491-8. doi: 10.1007/s00384-009-0854-4. Epub 2009 Nov 27.
- Background: PubMed 23876362Kulemann B, Timme S, Seifert G, Holzner PA, Glatz T, Sick O, Chikhladze S, Bronsert P, Hoeppner J, Werner M, Hopt UT, Marjanovic G. Intraoperative crystalloid overload leads to substantial inflammatory infiltration of intestinal anastomoses-a histomorphological analysis. Surgery. 2013 Sep;154(3):596-603. doi: 10.1016/j.surg.2013.04.010. Epub 2013 Jul 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Jennings, MD principal investigator
Colorado Joint Replacement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre Operative Oral Fluids in people with Arthroplasty, Replacement, Knee, run by Colorado Joint Replacement at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: Change is patients weight from baseline at pre op to two weeks post op.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03719378, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.