Traditional vs Oral Fluid Management in Total Knee Arthroplasty

NCT03719378 | Completed Results

• 1 other identifier: 1060593
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Arthroplasty, Replacement, Knee

Keywords

Fluid Management

Outcome Measures

Primary Outcomes (1)

• Body Weight

  Patient Weight will be monitored

  Change is patients weight from baseline at pre op to two weeks post op.

Secondary Outcomes (17)

• Knee Range of Motion

  Post Op Day 1, 2 Weeks and 6 Weeks Post Op

• Leg Anthropometric (Girth) Measurements

  Post op Day 1, 2 weeks and 6 weeks Post Op

• Number of Participants With Requiring Transfusions

  intra operative, Post Op Day #1 or #2

• Number of Participants With Off Wound Complications Post Operative

  Up to 6 weeks Post OP

• Number of Participants With Thromboembolic Disease

  Post Opeartive until the 6 week follow up appointment

Other Outcomes (3)

• Number of Participants With Adverse Events

  While in hospital until the 6 week follow up appointment

• Blood Pressure

  Daily up to 2 days while hospitalized

• Total Number of Patients That Received Any Pressor Drugs

  Up to Day 1 Post op

Study Arms (2)

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.

Other: Pre Operative Oral Fluids

Interventions

Pre Operative Oral Fluids OTHER

Patients will be self hydrating prior to their total knee replacement.

Oral Fluid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Volume-dependent cardiac conditions:
• Aortic stenosis
• Pulmonary valve stenosis
• Subaortic stenosis
• Severe Aortic Insufficiency
• Chronic systolic heart failure
• 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

Sponsors & Collaborators

• Colorado Joint Replacement: lead

Study Sites (1)

Colorado Joint Replacement

Denver, Colorado, 80210, United States

Location

Related Publications (3)

• 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.

  PMID: 19212167 BACKGROUND

• Marjanovic 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.

  PMID: 19943164 BACKGROUND

• Kulemann 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.

  PMID: 23876362 BACKGROUND

Results Point of Contact

• Title: Rose Johnson, CCRP Research Lead
• Organization: Colorado Joint Replacement

roseannjohnson@centura.org

3032602940

Study Officials

• Jason Jennings, MD

  Colorado Joint Replacement

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: October 25, 2018
• Study Start: October 13, 2015
• Primary Completion: September 10, 2018
• Study Completion: September 10, 2018
• Last Updated: March 16, 2021
• Results First Posted: March 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)