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Fast-track ProtocolPhase 4NCT06881121

IMPLICATION OF FAST-TRACK PROTOCOL FOR HIP FRACTURE FIXATION IN ALEXANDRIA UNIVERSITY HOSPITALS

A Phase 4 study testing Fast-track protocol for hip fracture fixation in people with Fast-track Protocol and Hip Fracture, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present study aims to evaluate the impact of fast-track protocol of hip fracture fixation within 48 hours on patients' mortality and morbidities. Primary aim is to observe the incidence of 30-day mortality of patients with hip fractures admitted to the operating room (OR) for fixation within 48 hours of the trauma… Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Fast-track protocol for hip fracture fixation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteEgypt
Study dates
1 Apr 2025to 1 Nov 2025
Phase
Phase 4
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 50 years.
  • ASA physical status class I, II or III.

Who cannot join

  • Poly-trauma patients.
  • Patients with history of sensitivity to the studied drugs.
  • Psychiatric disease or seizure disorder requiring medication within the previous 2 years.
  • Opioid tolerant patients.
  • Patients with preoperative cognitive dysfunction.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of medicine Alexandria University

    Alexandria, Egypt, Alexandria Governorate

Other trials in Egypt

About this study

Official title: IMPLICATION OF FAST-TRACK PROTOCOL FOR HIP FRACTURE FIXATION IN ALEXANDRIA UNIVERSITY HOSPITALS: PROSPECTIVE CONTROLLED CLINICAL STUDY

The present study aims to evaluate the impact of fast-track protocol of hip fracture fixation within 48 hours on patients' mortality and morbidities. Primary aim is to observe the incidence of 30-day mortality of patients with hip fractures admitted to the operating room (OR) for fixation within 48 hours of the trauma event and to asses Deep vein thrombosis incidence, Pulmonary embolism incidence, Post-operative cognitive dysfunction, length of hospital stay.,Length of ICU stay,Patients who needed hospital readmission and the reasons and the success of the postoperative rehabilitation status.

Read the detailed description

One hundred and fifty adult patients of American Society of Anesthesiologists (ASA) physical status I, II or III, age ≥ 50 years will be admitted to the department of orthopaedics surgery and traumatology, El Hadara University Hospital and scheduled for internal fixation under either spinal or general anaesthesia starting from January 2025. Patients will be divided into two groups: Group Fast pathway: Seventy-five patients treated according to fast-track protocol. Group Conventional pathway: Seventy-five patients who failed to be included in the fast track protocol will be included in the conventional (Non-Fast) pathway.

Preoperative evaluation and preparation: Evaluation of the patients will be carried out during the preoperative visit through proper history taking, clinical examination and routine laboratory investigations including complete blood picture, coagulation profile, blood urea, serum creatinine, serum electrolytes (sodium and potassium), fasting blood glucose, liver function tests and any other investigations needed. Serum lactate level informed written consent from all individual participants included in this study will be obtained during the preoperative visit. ECG, Echocardiograhy and Doppler lower limb examination for all patients. Fast-track care: The fast-track care will be started on admission to the hospital provided that the patients have fresh fractures. The patients will be examined in the emergency unit and directly transported to the radiology department with a tentative diagnosis of hip fracture. Preoperative treatment like administration of fascia iliaca compartment block (FICB) with a volume of 40 ml bupivacaine 0.25%, oxygen and prevention of pressure sores will be started. On arrival at the orthopaedic ward, standardised nursing routines (pain control, nutrition, fluid therapy and prevention of pressure sores) will begin. All patients with hip fracture will be scheduled for surgery within 48 hours. Whenever possible, all patients will be mobilised on the first postoperative day with a physiotherapist.

Specific comorbidities plan: Anaemia and blood transfusion: Packed RBCs transfusion will be ordered if preoperative Hb is < 8 gm/dL or 10 gm/dL in the presence of history of ischemic heart disease. Strategies to reduce blood loss include expediting surgery and minimising operating time, and the use of tranexamic acid. Cardiac condition assessment: An echocardiography will be ordered immediately, however surgery will not be delayed pending the results of echocardiography for undiagnosed ischemia; anaesthesia will instead proceed with invasive blood pressure monitoring and particular attention paid to maintaining cardiovascular stability through the use of lower doses of anaesthesia, i.v. fluids and vasoactive drugs as appropriate. Anti-platelets, anticoagulants and spinal anaesthesia: In case of the use of single antiplatelet therapy, including clopidogrel, spinal or general anesthesia will be allowed to proceed on a risk/benefit basis. (i) For patients taking vitamin K antagonists, spinal anaesthesia may be undertaken once the international normalised ratio (INR) is 1.5. Those patients presenting with an INR of >1.5 will receive an initial dose of vitamin K as soon as possible (i.e. in the emergency department), with further vitamin K or prothrombin complex concentrate if the INR remains >1.5 after 4-6 h. Bridging therapy (e.g. heparin infusion) will be ordered for complex patients like those with a metallic heart valve. (ii) For patients with direct-acting oral anticoagulant (DOAC), spinal or general anaesthesia will be allowed after two half-lives have elapsed. CKD patients: If creatinine > 2 mg/dl, this will need additional precautions:

  • Potentially nephrotoxic drugs will be stopped e.g. NSAIDs, ACEI, diuretics. - Good hydration will be ensured. - Patients will be catheterised and a fluid balance chart will be started. Surgery will be allowed to proceed after ensuring good urine output. All patients who failed to be included in the fast track protocol (non-fast track) will be managed accordingly and followed, and the results will be compared to the fast track group. Pre-anaesthetic preparation and premedication: Fasting hours (6 hours to solids and 2 hours to clear fluids). Thrombotic prophylaxis (enoxaparin 40 mg) will be started 12 hours before surgery unless on bridging therapy. Antiseptic shower will be provided. Antibiotic prophylaxis: single dose ceftriaxone 2 g intravenously will be given 1 hour before surgical incision according to the hospital policy. Fluids and nutrition: Intravenous fluid (Ringer's) administered at a rate of 1 litre over 8 hours or according to renal and cardiac recommendations. A resuscitation fluid bolus of 5-10 ml/kg will be considered. On arrival to the operative theatre: A peripheral cannula (18G) will be inserted to all patients. A multichannel monitor (Dräger® Infinity vista XL) will be connected to the patient to display continuous electrocardiography monitoring for heart rate (beat/min) and rhythm, noninvasive arterial blood pressure (NIBP), arterial oxygen saturation (SpO2) and end-tidal carbon dioxide (ETCO2).

Anaesthesia: Patients will receive either spinal or general anaesthesia with FICB. Patients will be given spinal anesthesia with a maximum dose of 2.5 ml 0.5% hyperbaric bupivacaine at the L3/4 interspaces (alternatively at the L2/3 or L4/5 interspaces) under complete aseptic technique. If the patient has contraindication to spinal anaesthesia, general anaesthesia will be conducted. General Anaesthesia: preoxygenation for 3 minutes, standard anaesthesia will be induced with propofol in increments up to 2mg/kg till loss of verbal response, fentanyl 1μg/kg and atracurium 0.5 mg/kg intravenously to facilitate tracheal intubation or laryngeal mask airway (LMA) insertion. Anaesthesia will be maintained with 50% oxygen in air and isoflurane 1-1.5 MAC to maintain adequate depth of anaesthesia. The haemodynamic variables (eg, heart rate or blood pressure) will be maintained within 20% of the preoperative baseline values and if not, patients will be treated with additional boluses of fentanyl 0.5 mcg/kg intraoperatively as needed. Mechanical ventilation will be performed with a constant tidal volume of 6-8 ml/ kg and a respiratory rate of 10 to 12 cycles/min to maintain the end-tidal carbon dioxide tension between 35 and 40 mmHg and an oxygen saturation of ≥ 98 % with 50 % oxygen in air. Incremental doses of atracurium 0.1 mg/kg will be administered to maintain muscle relaxation according to nerve stimulator. The FICB: After spinal or general anaesthesia, the patient will be placed in complete supine position with the legs extended flattened to maximize access to the inguinal area, although palpation of a femoral pulse is a useful landmark, it is not required because the artery is quickly visualized by placement of the transducer transversely on the inguinal crease, followed by slow movement laterally or medially. Tilting the probe while pressing helps to identify the hyperechoic fascia iliaca superficial to the hypoechoic iliopsoas muscle. Medially, the femoral nerve is visualized deep to the fascia and lateral to the artery. Laterally, the sartorius muscle is identified by its typical triangular shape when compressed by the transducer. The goal is to place the needle tip under the fascia iliaca approximately at a lateral third of the line connecting the anterior superior iliac spine to the pubic tubercle (the injection is made several centimeters lateral to the femoral artery) and to deposit a volume of 40 ml bupivacaine 0.25%. A proper injection will result in the separation of the fascia iliaca by the local anaesthetic in the medial-lateral direction from the point of injection as described. In both types of Anaesthesia: if the MAP drops below 60 mmHg, ephedrine 10 mg IV bolus and fluid bolus will be given and repeated if required. Atropine 0.5 mg IV bolus will be given if HR decreases to less than 50 beats/min. Normothermia will be maintained using bair hugger and warm intravenous fluids. Urinary catheter will be inserted for monitoring of urine output. All the procedures will be performed by expert surgeons with a clinical experience of more than 5 years. At the end of surgery, anaesthesia will be discontinued; residual neuromuscular block will be reversed by atropine 0.02 mg/kg and neostigmine 0.025 - 0.05 mg/kg. Extubation will be performed awake after the return of protective airway reflexes. Anti-emetic measures: ondansetron 8 mg intravenously will be administered at the end of surgery. Postoperative Management: All patients will be transferred to the intermediate care unit and will be closely monitored continuously for the next 24 hours. Multimodal analgesia in the form of intravenous paracetamol 1 g/8 hours (Perfalgan® 100 ml vial UPSA France) and intravenous ketorolac 15 mg/8 hours will be administered for postoperative pain control. If the VAS score is ≥ 4, FICB will be reconsidered with 40 ml 0.1 % bupivacaine. The incidence of postoperative nausea and vomiting (PONV) will be assessed by a nurse for the first 24 hours and only 2 possible answers will be accepted (yes or no). Nausea is defined as subjective sensation of discomfort associated with the awareness of the urge to vomit. Vomiting is defined as a forceful expulsion of gastric contents through the mouth.Rescue antiemetic ondansetron 8 mg intravenously will be given if the patient has persistent nausea or more than a single episode of vomiting. Removal of urinary catheter will be encouraged as early as possible after surgery. DVT prophylaxis: LMWH will be continued postoperatively no earlier than 4 hours after the procedure. Rehabilitation: Physiotherapy assessment and early mobilisation of all patients the day following surgery will be done. Nutrition management: multidisciplinary team including orthogeriatricians, occupational therapists and nutritionists will be organized for optimization of nutrition state. Combined oral and parenteral supplementation will be ordered to increase the daily nutritional intake to near-optimum levels (nutrition levels based on basal demand of 25 kcal/kg body weight/day and fluid levels based on 30 mL/kg body weight/day) or according to renal and cardiac recommendations.

Being tested
Fast-track protocol for hip fracture fixation
Medical subject headings
Hip Fractures

What participants receive

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

  • Fast-track protocol for hip fracture fixationProcedure or surgery

    Fast-track protocol implication on mortality and morbidities in hip fracture fixation

Study groups in NCT06881121
Study groupRoleWhat they receive
Group Fast pathwayExperimentalGroup Fast pathway: Seventy-five patients treated according to fast-track protocol.
Receives: Procedure: Fast-track protocol for hip fracture fixation
Group Conventional pathwayNo interventionGroup Conventional pathway: Seventy-five patients who failed to be included in the fast track protocol will be included in the conventional (Non-Fast) pathway.

What is being measured

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

  1. 30 days mortality

    Mortality: The follow-up time will be 30 days either through postoperative visits or phone call and documented. Time to death will be calculated from admission to possible event.

    Measured: 30 days post operative

Secondary outcomes (16)
  1. Time to surgery

    Time to surgery (TTS) will be calculated as hours from fracture time to surgery.

    Measured: Hours before surgery

  2. Duration of surgery

    Duration of surgery (mins).

    Measured: During Surgery

  3. Deep vein thrombosis incidence

    Any patient with suspected signs of DVT postoperatively will be confirmed with a doppler examination and documented.

    Measured: Post opertaive day 5

  4. Pulmonary embolism incidence

    The diagnosis of pulmonary embolism if suspected clinically by Wells' criteria will be confirmed with pulmonary angiography, transferred to ICU and managed accordingly.

    Measured: Post operative day 5

  5. Thromboembolic complications

    Thromboembolic complications: as stroke and MI will be confirmed by CT brain and cardiac enzymes and transferred to ICU and managed accordingly.

    Measured: Post opertaive day 5

  6. Length of ICU stay

    Length of ICU stay (days): The numbers of days from ICU admission to discharge.

    Measured: Post opertaive day 5

  7. Length of hospital stay

    Length of hospital stay (days): LOS is defined as the number of days between the operation and discharge from the hospital.

    Measured: Post opertaive day 5

  8. Cause of delay in non-fast track protocol.

    Cause of delay in non-fast track protocol.

    Measured: Perioperative

  9. Cognitive dysfunction

    Cognitive dysfunction using Mini Mental State Examination (MMSE) test will be recorded

    Measured: T0: during preoperative visit. T1: 120 minutes postoperatively. T2: 24 hours postoperatively.

  10. Incidence of postoperative nausea and vomiting

    Incidence of postoperative nausea and vomiting in the first 24 hours postoperatively.

    Measured: 24 hours post operative

  11. Number of patients requiring rescue anti-emetic

    Number of patients requiring rescue anti-emetic postoperatively will be recorded.

    Measured: 24 hours post operative

  12. Incidence of infection and complications

    Incidence of infection and complications: as chest infection, UTI and surgically related infections.

    Measured: Post opertaive day 5

  13. Serum lactate level (mmol/L)

    Serum lactate level (mmol/L): will be measured preoperatively and 12 hours postoperatively for detection of possible hypoperfusion.

    Measured: 12 hours preoperative and 24 hours post operative

  14. Patients who needed hospital readmission

    Patients who needed hospital readmission and the reasons.

    Measured: Up to 30 days postoperative

  15. The reasons of hospital readmission

    The reasons of hospital readmission

    Measured: Up to 30 days postoperative

  16. Rehabilitation status

    Rehabilitation status will be assessed during the 30 day postoperative follow up period: the following will be assessed during postoperative visit - Patients who walked assisted. - Patients who continued to need nursing home care.

    Measured: Up to 30 days postoperative

Timeline

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

  1. First posted18 Mar 2025
  2. Study start1 Apr 2025
  3. Primary completion1 Oct 2025
  4. Study completion1 Nov 2025

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06881121
Sponsor's protocol ID
IMPLICATION OF FAST-TRACK
Status last verified
Dec 2025
First submitted
5 Mar 2025
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Throug clinical trials

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fast-track protocol for hip fracture fixation in people with Fast-track Protocol and Hip Fracture, run by Alexandria University at 1 site in Egypt.

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 2 inclusion and 5 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 15 Dec 2025. 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 Egypt. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

30 days mortality (time frame: 30 days post operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Dec 2025.

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