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RecruitingPhase IIIInterventional

Metoclopramide for avoiding pneumonia after stroke

After a stroke, many people have trouble swallowing safely. This makes it easy for saliva, food, or stomach contents to accidentally enter the lungs. This can cause a serious chest infection called pneumonia, which is a leading cause of harm and death after a stroke. This clinical trial, called MAPS-2, tests whether an anti-sickness medicine called metoclopramide can prevent pneumonia. Metoclopramide encourages the stomach to empty more quickly, which may stop sickness and reflux from reaching the lungs. Patients who join will receive either metoclopramide or a dummy treatment (saltwater) three times a day for up to two weeks, given through a drip or feeding tube. Hospital staff will monitor their recovery closely, followed by a phone call six months later to see how they are doing. The aim is to find out if this simple treatment saves lives and improves recovery.

At a glance

Status
Recruiting
Phase
Phase III
Sponsor
University of Nottingham
Enrolment target
2,100
Start
28 Feb 2022
Estimated completion
30 Apr 2027

What is this study about?

Having a stroke can affect the body in many ways, and one common complication is difficulty swallowing (known medically as dysphagia). When a person cannot swallow normally, food, drink, or stomach acid can easily go down the wrong way into the breathing tubes and lungs. This can cause pneumonia, a lung infection that delays recovery, lengthens hospital stays, and can be life-threatening.

Metoclopramide is a medicine that doctors have used safely for many years to treat sickness and nausea. It works by helping the stomach empty its contents into the bowel more quickly. An earlier, smaller study showed that giving metoclopramide to stroke patients who struggle to swallow seemed to protect them from developing pneumonia. Researchers now want to run a much larger trial across several UK hospitals to see if this treatment genuinely helps people survive and recover better.

In this study, half of the participants will receive metoclopramide, while the other half will receive a harmless saltwater solution (a placebo). Comparing the two groups allows doctors to know for certain whether any improvement is due to the medicine. The findings could change how stroke care is delivered across the NHS, potentially offering an affordable, accessible way to protect vulnerable patients.

Key takeaways

  • Tests whether an anti-sickness drug (metoclopramide) prevents pneumonia after a stroke.
  • Aimed at adults admitted to hospital with a stroke and swallowing problems within 24 hours.
  • Treatment is given three times daily through a drip or feeding tube for up to two weeks.
  • Participation lasts six months and finishes with a simple telephone check-in.
  • Taking part is voluntary and will not interrupt regular NHS stroke treatments.

Who may be eligible?

This trial is designed for adults aged 18 and over who have been admitted to hospital with a moderate to severe stroke within the previous 24 hours. To take part, the person must also have swallowing difficulties, meaning they cannot safely eat or drink regular meals, or they may be too drowsy to have their swallowing tested safely.

People cannot join the study if they already have pneumonia or signs of a chest infection when they arrive at hospital. They will also be excluded if they are already taking antibiotics for an infection, or if they have medical reasons or allergies that make taking metoclopramide unsafe.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Aged 18 or older
  2. Admitted to hospital with a stroke within the last 24 hours
  3. Struggling to swallow food and drink safely, or too drowsy to test
  4. Do not currently have a chest infection or pneumonia
  5. Able and safe to take metoclopramide
Answer every question to see your result.

What does participation involve?

Taking part in the study lasts for 6 months in total. While in hospital, the participant will receive either the study medicine (metoclopramide) or the dummy treatment three times a day for up to 14 days, or until they leave hospital if that happens sooner. The treatment is given through a vein (via a drip) or through a soft feeding tube passed through the nose into the stomach.

During the first two weeks, the hospital care team will check on the participant every day to look for any signs of pneumonia or side effects. On day 14, a doctor will carry out a physical assessment to see how well the patient is recovering from their stroke. After six months, a member of the research team will phone the participant or their family carer at home to ask about their quality of life, recovery, and any ongoing swallowing problems.

Potential risks and benefits

Participants might benefit if the medicine successfully prevents pneumonia, which could help them recover faster, but this cannot be promised. The study will also help future stroke patients by improving NHS care. Like all medications, metoclopramide can cause side effects, such as sleepiness, restlessness, or temporary muscle twitches, though serious reactions are rare. Joining is completely voluntary. Patients or their representatives can withdraw at any time without giving a reason, and this will not affect the standard of hospital care they receive.

Locations (55)

  • Royal London Hospital
    Approximate
    London, England
  • Addenbrooke's Hospital
    Approximate
    Cambridge, England
  • Queens Medical Centre
    Approximate
    Nottingham, England
  • West Suffolk Hospital
    Approximate
    Bury St Edmunds, England
  • Royal Victoria Infirmary
    Approximate
    Newcastle Upon Tyne, England
  • Leighton Hospital
    Unverified
    Crewe, England
  • James Cook University Hospital
    Unverified
    Middlesbrough, England
  • Milton Keynes University Hospital
    Unverified
    Milton Keynes, England
  • St George's Hospital
    Unverified
    London, England
  • South West Acute Hospital
    Unverified
    Enniskillen, Northern Ireland
  • King's College Hospital
    Unverified
    London, England
  • Northampton General Hospital
    Unverified
    Northampton, England

Common questions

What is a placebo and why is it used?

A placebo is a dummy treatment that looks identical to the real medicine but contains no active drug (in this case, plain saltwater). It helps researchers prove whether any health improvements are truly caused by metoclopramide.

Can family members make the decision to take part?

Yes. Because a stroke can make patients confused, drowsy, or unable to speak, a family member or legal representative can give permission for them to join the trial if appropriate.

Will taking part change standard stroke treatment?

No. Participants continue to receive all standard, high-quality NHS stroke care, including specialist nursing, physiotherapy, and speech therapy.

Is metoclopramide a brand-new medicine?

No. Metoclopramide has been widely used in the NHS for decades to treat sickness, so its safety and common side effects are already well understood by doctors.

Will participants have to make extra hospital visits?

No extra hospital visits are required. Treatment and checks happen during the normal hospital stay, and the final check-up at six months is done over the telephone.

How to find out more

Christine Roffe

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Metoclopramide for avoiding pneumonia after stroke…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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