Arthroplasty, Hip ReplacementPhase 2/3ImmunehipNCT02580214
Immunonutrition in Total Hip Arthroplasty
A Phase 2/3 study testing Impact in people with Arthroplasty, Hip Replacement and Perioperative Care, run by Federal University of Mato Grosso at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthroplasty, Hip Replacement, Perioperative Care, Nutritional Support
- What is being tested?
- Impact
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to Nov 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We included adult patients (18-80 y/o) of both sex having a hip osteoarthrosis and candidates of elective THA.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Protocol Of Perioperative Care Plus Immunonutrition Enhances Recovery After Total Hip Arthroplasty. A Randomized Pilot Study
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
Read the detailed description
A large broad of evidence has shown that traditional perioperative care have a weak scientific basis and needs to be changed. Multimodal or fast-track protocols of perioperative care for abdominal surgery have been associated with lower morbidity, lower costs and faster postoperative recovery when compared to traditional care . Similarly the prescription of perioperative immune nutrition for 5-7 days before major abdominal surgery may decrease the risk of infections and reduce postoperative length of stay (LOS). Interestingly there is lack of studies on multimodal protocols of enhanced recovery and on immune nutrition in elective total hip arthroplasty (THA). In Brazil, the ACERTO (an acronym in Portuguese for acceleration of postoperative recovery) protocol is a multimodal protocol of perioperative care that includes: shortening of preoperative fasting with carbohydrates (CHO)-rich drinks up to 2h before surgery, restriction of intravenous fluids and early postoperative re-feeding and mobilization. Recently as a dynamic protocol the Acerto protocol included the recommendation of perioperative immune nutrition. All the elements of the protocol are based on evidence and are recommended by various international guidelines and consensus. Thus, the aim of this pilot study was to investigate whether the use of the Acerto multimodal protocol plus preoperative immune nutrition would decrease the length of stay and acute phase inflammation in patients submitted to THA.
METHODS This was a prospective randomized pilot study. All procedures were performed at São Mateus Hospital (Cuiabá, Brazil) from May 2012 to February 2013. The study was approved by the Research Ethics Committee of the Júlio Müller University Hospital (Federal University of Mato Grosso) and all patients signed a term of informed consent.
Inclusion and exclusion criteria. The investigators included adult patients of both sex having a hip osteoarthrosis and candidates of elective THA. 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); and severe malnutrition (history of loss of 10% of body weight over the last 6 months). The investigators also excluded patients who did not have their blood samples taken at the scheduled time and those who broke perioperative protocol, e.g. the non-intake of the immune supplement in the Acerto group.
Design of the study. Patients were consecutively included and randomized into two groups: Group Control and ACERTO group with the aid of electronic software of random numbers available at www.graphpad.com. All patients were assessed by a multidisciplinary team, who carried out a nutrition assessment, preoperative education, and collected the relevant anthropometric, biochemical and clinical data.
Anesthesia and operative technique. Antibiotic prophylaxis was done with 2g of intravenous kefazolin at the time of anesthetic induction. Measures were taken against postoperative nausea and vomiting (PONV) according to the protocol applied by the anesthesia team and will be discussed in this paper. Preoperative sedation was done with intravenous midazolam (0.03 to 0.1mg/kg) and propofol (30 to 60 mcg/kg/min) No general anesthetic was applied in both groups. All subjects received epidural neuro-axis blockage at L3-L4 space with ropivacain 7.5% to 10% (150-200mg) and morphine chlorate 2mg (30 to 50 micrograms/kg). The surgical access of the hip was done by anterior-lateral approach. The investigators used in all cases hybrid type total arthroplasty (cementation of the femoral component and fixation of the acetabular component by means of pressure fitting of the implant to the bone and the addition of screws to the acetabular cup when necessary).
Carbohydrate drink Patients belonging to the Acerto group received a drink (200 mL) containing water plus 12% maltodextrin 2h before the induction of anesthesia.
Immune supplementation therapy. The patients in the ACERTO group received an immune supplement containing arginine, w-3 fatty acids, nucleotides, and vitamins (Impact; Nestlé; Sao Paulo, Brazil. Formula: proteins: 23% (77% calcium caseinate, 23% arginine); carbohydrates: 52% (100% maltodextrin); lipids: 25% (68% fish oil; 20% medium-chain triglycerides and 12% corn oil), vitamins and electrolytes) for five days prior to surgery, with a daily dosage of thress units (600ml per day in total).
Blood samples. Blood samples were collected preoperatively and at the 2nd PO day and assayed for CRP assay.
Criteria for hospital discharge.
Discharge was signed by an orthopedic surgeon if all of these five parameters were fulfilled:
- patient is confident and willing to go home,
- no pain or pain controlled by oral analgesics,
- walking alone or with minimal help,
- no fever or signs of postoperative infection, and
- accepting normal oral diet
Outcome variables The main outcome variable was the postoperative length of stay. As secondary outcome variables it was compared the evolution of serum C-reactive protein (CRP) overtime.
Statistical analysis. The calculation of the sample was based on the premise that the intervention with the Acerto Project protocol would reduce the hospital stay length by 50%. For a β error (type II) of 20% and an α error (type I) of 5%, it was calculated that 15 patients in each group would be sufficient for this study. Investigators used paired and unpaired t-test when samples were homogeneous or the Mann-Whitney test or the Wilcoxon test if samples were heterogeneous. Categorical variables were compared by the chi square test or Fisher exact test. Statistical analyses were made using the Minitab 14 and the null hypothesis rejection was fixed at 0.05 (α=5%).
- Being tested
- Impact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImpactDietary supplement
600 ml of Impact, Nestle for 5 days prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Acerto | Experimental | Preoperative immune nutrition for 5 days (Impact, Nestle) Preoperative fasting of 2h with a drink containing 12% maltodextrine No intravenous fluids postoperatively Receives: Dietary Supplement: Impact |
| Control | No intervention | No immune nutrition Preoperative fasting of 6-8 h Crystalloid intravenous fluids until PO day 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of postoperative stay
days of postoperative stay until discharge up to 30 days
Measured: up to 30 days of the postoperative course
Secondary outcomes (1)
Serum C-reactive protein
Blood samples collected at anesthesia induction and again at PO day 2 to C-reactive protein assay
Measured: preoperative and 2nd PO day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startMay 2013
- Primary completionMar 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Hip ReplacementStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Mato Grosso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580214
- Sponsor's protocol ID
- FUMatogrossoSul
- Acronym
- Immunehip
- Status last verified
- Oct 2015
- First submitted
- 15 Oct 2015
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27038614
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Protocol Of Perioperative Care Plus Immunonutrition Enhances Recovery After Total Hip Arthroplasty. A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT02580214
- Acronym / sponsor ID
- Immunehip / FUMatogrossoSul
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Federal University of Mato GrossoUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
A large broad of evidence has shown that traditional perioperative care have a weak scientific basis and needs to be changed. Multimodal or fast-track protocols of perioperative care for abdominal surgery have been associated with lower morbidity, lower costs and faster postoperative recovery when compared to traditional care . Similarly the prescription of perioperative immune nutrition for 5-7 days before major abdominal surgery may decrease the risk of infections and reduce postoperative length of stay (LOS). Interestingly there is lack of studies on multimodal protocols of enhanced recovery and on immune nutrition in elective total hip arthroplasty (THA). In Brazil, the ACERTO (an acronym in Portuguese for acceleration of postoperative recovery) protocol is a multimodal protocol of perioperative care that includes: shortening of preoperative fasting with carbohydrates (CHO)-rich drinks up to 2h before surgery, restriction of intravenous fluids and early postoperative re-feeding and mobilization. Recently as a dynamic protocol the Acerto protocol included the recommendation of perioperative immune nutrition. All the elements of the protocol are based on evidence and are recommended by various international guidelines and consensus. Thus, the aim of this pilot study was to investigate whether the use of the Acerto multimodal protocol plus preoperative immune nutrition would decrease the length of stay and acute phase inflammation in patients submitted to THA.
METHODS This was a prospective randomized pilot study. All procedures were performed at São Mateus Hospital (Cuiabá, Brazil) from May 2012 to February 2013. The study was approved by the Research Ethics Committee of the Júlio Müller University Hospital (Federal University of Mato Grosso) and all patients signed a term of informed consent.
Inclusion and exclusion criteria. The investigators included adult patients of both sex having a hip osteoarthrosis and candidates of elective THA. 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); and severe malnutrition (history of loss of 10% of body weight over the last 6 months). The investigators also excluded patients who did not have their blood samples taken at the scheduled time and those who broke perioperative protocol, e.g. the non-intake of the immune supplement in the Acerto group.
Design of the study. Patients were consecutively included and randomized into two groups: Group Control and ACERTO group with the aid of electronic software of random numbers available at www.graphpad.com. All patients were assessed by a multidisciplinary team, who carried out a nutrition assessment, preoperative education, and collected the relevant anthropometric, biochemical and clinical data.
Anesthesia and operative technique. Antibiotic prophylaxis was done with 2g of intravenous kefazolin at the time of anesthetic induction. Measures were taken against postoperative nausea and vomiting (PONV) according to the protocol applied by the anesthesia team and will be discussed in this paper. Preoperative sedation was done with intravenous midazolam (0.03 to 0.1mg/kg) and propofol (30 to 60 mcg/kg/min) No general anesthetic was applied in both groups. All subjects received epidural neuro-axis blockage at L3-L4 space with ropivacain 7.5% to 10% (150-200mg) and morphine chlorate 2mg (30 to 50 micrograms/kg). The surgical access of the hip was done by anterior-lateral approach. The investigators used in all cases hybrid type total arthroplasty (cementation of the femoral component and fixation of the acetabular component by means of pressure fitting of the implant to the bone and the addition of screws to the acetabular cup when necessary).
Carbohydrate drink Patients belonging to the Acerto group received a drink (200 mL) containing water plus 12% maltodextrin 2h before the induction of anesthesia.
Immune supplementation therapy. The patients in the ACERTO group received an immune supplement containing arginine, w-3 fatty acids, nucleotides, and vitamins (Impact; Nestlé; Sao Paulo, Brazil. Formula: proteins: 23% (77% calcium caseinate, 23% arginine); carbohydrates: 52% (100% maltodextrin); lipids: 25% (68% fish oil; 20% medium-chain triglycerides and 12% corn oil), vitamins and electrolytes) for five days prior to surgery, with a daily dosage of thress units (600ml per day in total).
Blood samples. Blood samples were collected preoperatively and at the 2nd PO day and assayed for CRP assay.
Criteria for hospital discharge.
Discharge was signed by an orthopedic surgeon if all of these five parameters were fulfilled:
- patient is confident and willing to go home,
- no pain or pain controlled by oral analgesics,
- walking alone or with minimal help,
- no fever or signs of postoperative infection, and
- accepting normal oral diet
Outcome variables The main outcome variable was the postoperative length of stay. As secondary outcome variables it was compared the evolution of serum C-reactive protein (CRP) overtime.
Statistical analysis. The calculation of the sample was based on the premise that the intervention with the Acerto Project protocol would reduce the hospital stay length by 50%. For a β error (type II) of 20% and an α error (type I) of 5%, it was calculated that 15 patients in each group would be sufficient for this study. Investigators used paired and unpaired t-test when samples were homogeneous or the Mann-Whitney test or the Wilcoxon test if samples were heterogeneous. Categorical variables were compared by the chi square test or Fisher exact test. Statistical analyses were made using the Minitab 14 and the null hypothesis rejection was fixed at 0.05 (α=5%).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acerto | Experimental | Dietary Supplement: ImpactPreoperative immune nutrition for 5 days (Impact, Nestle) Preoperative fasting of 2h with a drink containing 12% maltodextrine No intravenous fluids postoperatively |
| Control | No intervention | –No immune nutrition Preoperative fasting of 6-8 h Crystalloid intravenous fluids until PO day 1 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We included adult patients (18-80 y/o) of both sex having a hip osteoarthrosis and candidates of elective THA.
Key exclusion criteria (8 listed)
- 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)
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 |
|---|---|---|
| Impact600 ml of Impact, Nestle for 5 days prior to surgery | Dietary supplement | Acerto |
Primary outcome
Length of postoperative stay
Time frame: up to 30 days of the postoperative course
days of postoperative stay until discharge up to 30 days
1 secondary outcome
Serum C-reactive protein
Time frame: preoperative and 2nd PO day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
- Derived from this study: PubMed 27038614Alito 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Impact in people with Arthroplasty, Hip Replacement and Perioperative Care, run by Federal University of Mato Grosso at 1 site in Brazil.
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 8 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 20 Oct 2015. 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 Brazil. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of postoperative stay (time frame: up to 30 days of the postoperative course). 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 NCT02580214, which also lists 1 linked publication.
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 20 Oct 2015; AzTrials last refreshed its copy on 30 Oct 2026.