Immunonutrition in Total Hip Arthroplasty

NCT02580214 | Completed Phase 2

• 1 other identifier: FUMatogrossoSul
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this pilot study was to investigate whether the use of a multimodal protocol of preoperative care plus preoperative immune nutrition would decrease the length of stay and acute phase inflammation in patients submitted to total hip arthroplasty (THA). The study was designed to be randomized and controlled, but not double blind. The patients were randomized to receive either preoperative care based on evidence plus immune nutrition for 5 days prior to surgery (Acerto group) or traditional preoperative care (control group). Main endpoints were length of stay and acute-phase postoperative response

Conditions

Arthroplasty, Hip Replacement; Perioperative Care; Nutritional Support

Outcome Measures

Primary Outcomes (1)

• Length of postoperative stay

  days of postoperative stay until discharge up to 30 days

  up to 30 days of the postoperative course

Secondary Outcomes (1)

• Serum C-reactive protein

  preoperative and 2nd PO day

Study Arms (2)

Acerto

EXPERIMENTAL

Preoperative immune nutrition for 5 days (Impact, Nestle) Preoperative fasting of 2h with a drink containing 12% maltodextrine No intravenous fluids postoperatively

Dietary Supplement: Impact

Control

NO INTERVENTION

No immune nutrition Preoperative fasting of 6-8 h Crystalloid intravenous fluids until PO day 1

Interventions

Impact DIETARY_SUPPLEMENT

600 ml of Impact, Nestle for 5 days prior to surgery

Acerto

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We included adult patients (18-80 y/o) of both sex having a hip osteoarthrosis and candidates of elective THA.

You may not qualify if:

• Patients were excluded if they had fasting glycemia greater than 200mg/dl
• Acquired immunodeficiency (AIDS)
• Renal failure (creatinin above 2 mg/dl)
• Cirrhosis
• Moderate or serious Alzheimer's disease (clinical dementia rating score between 2 and 3)
• An American Society of Anesthesiologists (ASA) score higher than 2
• Previous spinal surgery (arthrodesis) or THA (reviewing or changing the prosthetic)
• Severe malnutrition (history of loss of 10% of body weight over the last 6 months).

Sponsors & Collaborators

• Federal University of Mato Grosso: lead

Study Sites (1)

Gastroclinica

Cuiabá, Mato Grosso, 78048-150, Brazil

Location

Related Publications (1)

• Alito MA, de Aguilar-Nascimento JE. Multimodal perioperative care plus immunonutrition versus traditional care in total hip arthroplasty: a randomized pilot study. Nutr J. 2016 Apr 2;15:34. doi: 10.1186/s12937-016-0153-1.

  PMID: 27038614 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor, MD, PhD

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 20, 2015
• Study Start: May 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

BR (1)