Elderly PatientsNCT04451538

Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery

A study testing Nutritional intervention group in people with Elderly Patients and Malnutrition, run by Peking University First Hospital at 3 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 70 years and older
Conditions the study is for: Elderly Patients, Malnutrition, Hip Fractures
What is being tested?: Nutritional intervention group
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 3 sitesChina
Study dates: 28 Dec 2020to 2 Apr 2021
Phase: Interventional
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 70 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Age ≥70 years old;
Hospitalized for hip fracture, scheduled to undergo hip-fracture surgery within 48 hours;
Classified as malnutrition or at risk of malnutrition according to the short form mini-nutrition assessment (MNA-SF);
Provide written informed consents.

Who cannot join

Pathological fracture;
History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis before surgery;
Unable to communicate due to coma, severe dementia, or language barrier;
Unable to eat due to any disease in the gastrointestinal system;
Severe hepatic dysfunction (Child-Pugh class C), renal failure (requirement of renal replacement therapy), respiratory failure (requirement of respiratory support), cardiac insufficiency (New York Heart Association classification ≥IV), or American Socisty of Anesthesiologists classification ≥IV;
Preexisting organ injury before surgery (delirium, acute kidney injury, myocardial injury, etc.);
Other conditions that are considered unsuitable for study participation.

Trial locations and contacts

3 sites in 1 country.

China3 sites

Peking University First Hospital
Beijing, Beijing Municipality, 100034
Fourth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100048
Tianjin Orthopedic Hospital
Tianjin, Tianjin Municipality

Other trials in China

About this study

Official title: Impact of Perioperative Nutritional Intervention on Perioperative Outcomes of Elderly Patients Having Hip Fracture Surgery: A Randomized Control Trial

Hip fracture is one of the most frequently occurred injury in the elderly and usually requires surgical treatment. Malnutrition is common in elderly patients with hip fracture and is associated with worse outcomes. This study is designed to test the hypothesize that, in elderly patients with malnutrition or at risk of malnutrition and scheduled for hip-fracture surgery, perioperative nutritional intervention may reduce early complications and improve long-term survival.

Read the detailed description

Elderly patients with hip fracture have a high rate of malnutrition. In a cohort study of hip fracture patients aged 70 years or older, 18.8% have malnutrition and 44.6% are at risk of malnutrition. Increasing evidence suggest that preoperative nutritional status has a significant impact on clinical outcomes of elderly patients following surgery. For example, preoperative malnutrition or risk of malnutrition is associated with increased delirium, increased non-delirium complications, prolonged hospital stay, high mortality, and even worse long-term survival after surgery. We speculate that perioperative nutritional intervention may reduce postoperative delirium and improve early and long-term clinical outcomes in elderly hip-fracture patients. The purpose of this study is to observe the effect of perioperative nutritional intervention on early postoperative delirium and complications as well as long-term survival in the patients with malnutrition or at risk of malnutrition who are scheduled for hip-fracture surgery.

Conditions: Elderly Patients, Malnutrition, Hip Fractures, Nutritional Intervention, Perioperative Outcomes, Survival
Being tested: Nutritional intervention group, Control group
Keywords: Elderly patients, Malnutrition, Hip Fractures, Nutritional intervention, Perioperative outcomes, Long-term survival
Medical subject headings: Malnutrition, Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nutritional intervention groupDietary supplement
Supplemental nutritional support is provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase). For non-diabetic patients, ENSURE is provided (Abbott; 112.6 g (12 spoons, 500 kcal)/day, twice a day); for diabetic patients, GLUCERNA SR is provided (Abbott; 104 g [12 spoons, 440 kcal]/day, twice a day).
Control groupDietary supplement
Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase).

Study groups in NCT04451538
Study group	Role	What they receive
Nutritional intervention group	Experimental	Supplemental nutritional support is provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase). For non-diabetic patients, ENSURE is provided (Abbott; 112.6 g [12 spoon, 500 kcal]/day, twice a day); for diabetic patients, GLUCERNA SR is provided (Abbott; 104 g [12 spoon, 440 kcal]/day, twice a day). Receives: Dietary Supplement: Nutritional intervention group
Control group	Placebo comparator	Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase). Receives: Dietary Supplement: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of delirium or non-delirium complications after surgery
Delirium is assessed twice daily with Confusion Assessment Method (CAM) or CAM for the Intensive Care Unit (CAM-ICU) during the first 5 days after surgery. Non-delirium complications indicate newly occurred conditions (other than delirium) that are harmful to patients' recovery and required therapeutic intervention within 30 days after surgery.
Measured: Up to 30 days after surgery

Secondary outcomes (7)

Intensive care unit admission after surgery
Intensive care unit admission after surgery
Measured: Within 24 hours after surgery
Length of intensive care unit stay after surgery
Length of intensive care unit stay after surgery
Measured: Up to 30 days after surgery
Incidence of organ injury within 5 days after surgery
Organ injury includes delirium (assessed with CAM/CAM-ICU), acute kidney injury (assessed according to KDIGO [Kidney Disease: Improving Global Outcomes] Criteria), and myocardial injury (cardiac troponin I higher than upper normal limit).
Measured: Up to 5 days after surgery
Incidence of non-delirium complications after surgery
Non-delirium complications indicate newly occurred conditions (other than delirium) that are harmful to patients' recovery and required therapeutic intervention within 30 days after surgery.
Measured: Up to 30 days after surgery
Length of hospital stay after surgery
Length of hospital stay after surgery
Measured: Up to 30 days after surgery.
Cognitive function at 30 days after surgery
Cognitive function is assessed with the Modified Telephone Interview for Cognitive Status (TICS-m) which is a 12-item questionnaire that verbally assesses global cognitive function via telephone. The score ranges from 0 to 50, with higher score indicating better function.
Measured: At 30 days after surgery.
Quality of life at 30 days after surgery
Quality of life is assessed with the World Health Organization Quality of Life brief version (WHOQOL-BREF) which is a 24-item questionnaire that assesses the quality of life in physical, psychological, social relationship and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function.
Measured: At 30 days after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Dec 20202 Apr 2021

First posted30 Jun 2020
Study start28 Dec 2020
Primary completion2 Mar 2021
Study completion2 Apr 2021

Why it stopped: The trial was stopped prematurely due to slow recruitment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (42)Papers the sponsor has linked to this study.
Other trials for Elderly PatientsStudies of the same condition, open and under way.
More trials run by Peking University First HospitalThe sponsor's other registered studies.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04451538
Sponsor's protocol ID: 2019-322
Status last verified: Jul 2025
First submitted: 26 Jun 2020
Last updated: 5 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Brauer CA, Coca-Perraillon M, Cutler DM, Rosen AB. Incidence and mortality of hip fractures in the United States. JAMA. 2009 Oct 14;302(14):1573-9. doi: 10.1001/jama.2009.1462.
PubMed 19826027
Membership of the Working Party; Griffiths R, Alper J, Beckingsale A, Goldhill D, Heyburn G, Holloway J, Leaper E, Parker M, Ridgway S, White S, Wiese M, Wilson I. Management of proximal femoral fractures 2011: Association of Anaesthetists of Great Britain and Ireland. Anaesthesia. 2012 Jan;67(1):85-98. doi: 10.1111/j.1365-2044.2011.06957.x.
PubMed 22150501
Mak JC, Cameron ID, March LM; National Health and Medical Research Council. Evidence-based guidelines for the management of hip fractures in older persons: an update. Med J Aust. 2010 Jan 4;192(1):37-41. doi: 10.5694/j.1326-5377.2010.tb03400.x.
PubMed 20047547
Cram P, Lu X, Kaboli PJ, Vaughan-Sarrazin MS, Cai X, Wolf BR, Li Y. Clinical characteristics and outcomes of Medicare patients undergoing total hip arthroplasty, 1991-2008. JAMA. 2011 Apr 20;305(15):1560-7. doi: 10.1001/jama.2011.478.
PubMed 21505134
Bottle A, Aylin P. Mortality associated with delay in operation after hip fracture: observational study. BMJ. 2006 Apr 22;332(7547):947-51. doi: 10.1136/bmj.38790.468519.55. Epub 2006 Mar 22.
PubMed 16554334
Shiga T, Wajima Z, Ohe Y. Is operative delay associated with increased mortality of hip fracture patients? Systematic review, meta-analysis, and meta-regression. Can J Anaesth. 2008 Mar;55(3):146-54. doi: 10.1007/BF03016088.
PubMed 18310624
Moja L, Piatti A, Pecoraro V, Ricci C, Virgili G, Salanti G, Germagnoli L, Liberati A, Banfi G. Timing matters in hip fracture surgery: patients operated within 48 hours have better outcomes. A meta-analysis and meta-regression of over 190,000 patients. PLoS One. 2012;7(10):e46175. doi: 10.1371/journal.pone.0046175. Epub 2012 Oct 3.
PubMed 23056256
Espinosa KA, Gelvez AG, Torres LP, Garcia MF, Pena OR. Pre-operative factors associated with increased mortality in elderly patients with a hip fracture: A cohort study in a developing country. Injury. 2018 Jun;49(6):1162-1168. doi: 10.1016/j.injury.2018.04.007. Epub 2018 Apr 13.
PubMed 29674111
Smith T, Pelpola K, Ball M, Ong A, Myint PK. Pre-operative indicators for mortality following hip fracture surgery: a systematic review and meta-analysis. Age Ageing. 2014 Jul;43(4):464-71. doi: 10.1093/ageing/afu065. Epub 2014 Jun 3.
PubMed 24895018
Malafarina V, Reginster JY, Cabrerizo S, Bruyere O, Kanis JA, Martinez JA, Zulet MA. Nutritional Status and Nutritional Treatment Are Related to Outcomes and Mortality in Older Adults with Hip Fracture. Nutrients. 2018 Apr 30;10(5):555. doi: 10.3390/nu10050555.
PubMed 29710860
Yang Y, Zhao X, Dong T, Yang Z, Zhang Q, Zhang Y. Risk factors for postoperative delirium following hip fracture repair in elderly patients: a systematic review and meta-analysis. Aging Clin Exp Res. 2017 Apr;29(2):115-126. doi: 10.1007/s40520-016-0541-6. Epub 2016 Feb 12.
PubMed 26873816
Dyer CB, Ashton CM, Teasdale TA. Postoperative delirium. A review of 80 primary data-collection studies. Arch Intern Med. 1995 Mar 13;155(5):461-5. doi: 10.1001/archinte.155.5.461.
PubMed 7864702
McDaniel M, Brudney C. Postoperative delirium: etiology and management. Curr Opin Crit Care. 2012 Aug;18(4):372-6. doi: 10.1097/MCC.0b013e3283557211.
PubMed 22732435
Lat I, McMillian W, Taylor S, Janzen JM, Papadopoulos S, Korth L, Ehtisham A, Nold J, Agarwal S, Azocar R, Burke P. The impact of delirium on clinical outcomes in mechanically ventilated surgical and trauma patients. Crit Care Med. 2009 Jun;37(6):1898-905. doi: 10.1097/CCM.0b013e31819ffe38.
PubMed 19384221
Quinlan N, Rudolph JL. Postoperative delirium and functional decline after noncardiac surgery. J Am Geriatr Soc. 2011 Nov;59 Suppl 2:S301-4. doi: 10.1111/j.1532-5415.2011.03679.x.
PubMed 22091577

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Elderly Patients trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Perioperative Nutritional Intervention on Perioperative Outcomes of Elderly Patients Having Hip Fracture Surgery: A Randomized Control Trial
ClinicalTrials.gov ID: NCT04451538
Acronym / sponsor ID: 2019-322
Conditions: Elderly Patients, Malnutrition, Hip Fractures, Nutritional Intervention, Perioperative Outcomes, Survival
Keywords: Elderly patients, Malnutrition, Hip Fractures, Nutritional intervention, Perioperative outcomes, Long-term survival
Study type: Interventional
Recruitment status: TerminatedReason stopped: The trial was stopped prematurely due to slow recruitment.
Enrolment: 30 participants (actual)
Lead sponsor: Peking University First HospitalUniversity, hospital or other
Collaborators: Fourth Medical Center of PLA General Hospital, Tianjin Orthopedic Hospital
Study start: 28 Dec 2020 (actual)
Primary completion: 2 Mar 2021 (actual)
Study completion: 2 Apr 2021 (actual)
First posted: 30 Jun 2020 (actual)
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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Nutritional intervention group	Experimental	Dietary Supplement: Nutritional intervention groupSupplemental nutritional support is provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase). For non-diabetic patients, ENSURE is provided (Abbott; 112.6 g [12 spoon, 500 kcal]/day, twice a day); for diabetic patients, GLUCERNA SR is provided (Abbott; 104 g [12 spoon, 440 kcal]/day, twice a day).
Control group	Placebo comparator	Dietary Supplement: Control groupSupplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase).

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

Age ≥70 years old;
Hospitalized for hip fracture, scheduled to undergo hip-fracture surgery within 48 hours;
Classified as malnutrition or at risk of malnutrition according to the short form mini-nutrition assessment (MNA-SF);
Provide written informed consents.

Key exclusion criteria (7 listed)

Pathological fracture;
History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis before surgery;
Unable to communicate due to coma, severe dementia, or language barrier;
Unable to eat due to any disease in the gastrointestinal system;
Severe hepatic dysfunction (Child-Pugh class C), renal failure (requirement of renal replacement therapy), respiratory failure (requirement of respiratory support), cardiac insufficiency (New York Heart Association classification ≥IV), or American Socisty of Anesthesiologists classification ≥IV;

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
Nutritional intervention groupSupplemental nutritional support is provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase). For non-diabetic patients, ENSURE is provided (Abbott; 112.6 g (12 spoons, 500 kcal)/day, twice a day); for diabetic patients, GLUCERNA SR is provided (Abbott; 104 g [12 spoons, 440 kcal]/day, twice a day).	Dietary supplement	Nutritional intervention group
Control groupSupplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase).	Dietary supplement	Control group

Primary outcome

Incidence of delirium or non-delirium complications after surgery
Time frame: Up to 30 days after surgery
Delirium is assessed twice daily with Confusion Assessment Method (CAM) or CAM for the Intensive Care Unit (CAM-ICU) during the first 5 days after surgery. Non-delirium complications indicate newly occurred conditions (other than delirium) that are harmful to patients' recovery and required therapeutic intervention within 30 days after surgery.

7 secondary outcomes

Intensive care unit admission after surgery
Time frame: Within 24 hours after surgery
Length of intensive care unit stay after surgery
Time frame: Up to 30 days after surgery
Incidence of organ injury within 5 days after surgery
Time frame: Up to 5 days after surgery
Incidence of non-delirium complications after surgery
Time frame: Up to 30 days after surgery
Length of hospital stay after surgery
Time frame: Up to 30 days after surgery.
Cognitive function at 30 days after surgery
Time frame: At 30 days after surgery.
Quality of life at 30 days after surgery
Time frame: At 30 days after surgery.

Results and safety

The study was stopped early (reason given: The trial was stopped prematurely due to slow recruitment.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
Background: PubMed 19826027Brauer CA, Coca-Perraillon M, Cutler DM, Rosen AB. Incidence and mortality of hip fractures in the United States. JAMA. 2009 Oct 14;302(14):1573-9. doi: 10.1001/jama.2009.1462.
Background: PubMed 22150501Membership of the Working Party; Griffiths R, Alper J, Beckingsale A, Goldhill D, Heyburn G, Holloway J, Leaper E, Parker M, Ridgway S, White S, Wiese M, Wilson I. Management of proximal femoral fractures 2011: Association of Anaesthetists of Great Britain and Ireland. Anaesthesia. 2012 Jan;67(1):85-98. doi: 10.1111/j.1365-2044.2011.06957.x.
Background: PubMed 20047547Mak JC, Cameron ID, March LM; National Health and Medical Research Council. Evidence-based guidelines for the management of hip fractures in older persons: an update. Med J Aust. 2010 Jan 4;192(1):37-41. doi: 10.5694/j.1326-5377.2010.tb03400.x.
Background: PubMed 21505134Cram P, Lu X, Kaboli PJ, Vaughan-Sarrazin MS, Cai X, Wolf BR, Li Y. Clinical characteristics and outcomes of Medicare patients undergoing total hip arthroplasty, 1991-2008. JAMA. 2011 Apr 20;305(15):1560-7. doi: 10.1001/jama.2011.478.
Background: PubMed 16554334Bottle A, Aylin P. Mortality associated with delay in operation after hip fracture: observational study. BMJ. 2006 Apr 22;332(7547):947-51. doi: 10.1136/bmj.38790.468519.55. Epub 2006 Mar 22.
Background: PubMed 18310624Shiga T, Wajima Z, Ohe Y. Is operative delay associated with increased mortality of hip fracture patients? Systematic review, meta-analysis, and meta-regression. Can J Anaesth. 2008 Mar;55(3):146-54. doi: 10.1007/BF03016088.
Background: PubMed 23056256Moja L, Piatti A, Pecoraro V, Ricci C, Virgili G, Salanti G, Germagnoli L, Liberati A, Banfi G. Timing matters in hip fracture surgery: patients operated within 48 hours have better outcomes. A meta-analysis and meta-regression of over 190,000 patients. PLoS One. 2012;7(10):e46175. doi: 10.1371/journal.pone.0046175. Epub 2012 Oct 3.
Background: PubMed 29674111Espinosa KA, Gelvez AG, Torres LP, Garcia MF, Pena OR. Pre-operative factors associated with increased mortality in elderly patients with a hip fracture: A cohort study in a developing country. Injury. 2018 Jun;49(6):1162-1168. doi: 10.1016/j.injury.2018.04.007. Epub 2018 Apr 13.
Background: PubMed 24895018Smith T, Pelpola K, Ball M, Ong A, Myint PK. Pre-operative indicators for mortality following hip fracture surgery: a systematic review and meta-analysis. Age Ageing. 2014 Jul;43(4):464-71. doi: 10.1093/ageing/afu065. Epub 2014 Jun 3.
Background: PubMed 29710860Malafarina V, Reginster JY, Cabrerizo S, Bruyere O, Kanis JA, Martinez JA, Zulet MA. Nutritional Status and Nutritional Treatment Are Related to Outcomes and Mortality in Older Adults with Hip Fracture. Nutrients. 2018 Apr 30;10(5):555. doi: 10.3390/nu10050555.
Background: PubMed 26873816Yang Y, Zhao X, Dong T, Yang Z, Zhang Q, Zhang Y. Risk factors for postoperative delirium following hip fracture repair in elderly patients: a systematic review and meta-analysis. Aging Clin Exp Res. 2017 Apr;29(2):115-126. doi: 10.1007/s40520-016-0541-6. Epub 2016 Feb 12.
Background: PubMed 7864702Dyer CB, Ashton CM, Teasdale TA. Postoperative delirium. A review of 80 primary data-collection studies. Arch Intern Med. 1995 Mar 13;155(5):461-5. doi: 10.1001/archinte.155.5.461.
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.

Dong-Xin Wang, MD, PhD principal investigator

Peking University First Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional intervention group in people with Elderly Patients and Malnutrition, run by Peking University First Hospital at 3 sites in China.

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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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. Some participants in this study may receive a placebo. 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?

The study was stopped early (reason given: The trial was stopped prematurely due to slow recruitment.). Results are not available in the source record.

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?

Incidence of delirium or non-delirium complications after surgery (time frame: Up to 30 days after surgery). 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 NCT04451538, which also lists 42 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 5 Aug 2025.