Gastric Feeding for the Prevention of Stroke-Associated Pneumonia (FEED-SAP)
1. juni 2026 oppdatert av: Xinfeng Liu, Jinling Hospital, China
Comparing Early Post-pyloric Feeding Versus Gastric Feeding for the Prevention of Stroke-Associated Pneumonia in Patients With Severe Ischemic Stroke
This randomized controlled trial aims to compare the effectiveness of early post-pyloric feeding versus gastric feeding in preventing SAP in patients with severe ischemic stroke.
The main question to answer is whether post-pyloric feeding group is better than the gastric feeding group for preventing SAP.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study adopts a multicenter-center, randomized controlled, parallel-group, open-label trial design.
Patients with severe ischemic stroke who meet the inclusion criteria will be randomly assigned to the post-pyloric feeding group (experimental group) or the gastric feeding group (control group).
Both groups will receive standard stroke treatment and care.
The primary outcome measure is the incidence of SAP, with a follow-up period of 90 days.
The sample size is 174 cases, with 87 cases per group.
Studietype
Intervensjonell
Registrering (Antatt)
174
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yahui Guo, MD
- Telefonnummer: +86 13951834652
- E-post: 1185626794@qq.com
Studer Kontakt Backup
- Navn: Rui Liu, MD
- Telefonnummer: +86 15005144515
- E-post: liurui8616@163.com
Studiesteder
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210002
- Jinling Hospital, Medical School of Nanjing University, Nanjing
-
Ta kontakt med:
- Yahui Guo, MD
- Telefonnummer: +86 13951834652
- E-post: 1185626794@qq.com
-
Ta kontakt med:
- Rui Liu, MD
- Telefonnummer: +86 15005144515
- E-post: liurui8616@163.com
-
Underetterforsker:
- Yahui Guo, MD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years
- Diagnosis of severe ischemic stroke, with NIHSS score > 16 [15-16]
- Confirmed dysphagia via swallowing assessment (Kubota Water Swallowing Test ≥ grade 3, or confirmed aspiration risk by FEES/VFSS)
- Time from onset to enrollment ≤ 72 hours
- Expected survival ≥ 7 days
- Non-mechanically ventilated patients
- Signed informed consent from patient or legal representative.
Exclusion Criteria:
- Diagnosed with pneumonia upon admission
- High risk of gastrointestinal bleeding or perforation
- Intestinal obstruction or gastrointestinal obstruction
- Severe liver or kidney dysfunction
- Advanced malignant tumor
- Pregnancy or breastfeeding
- Refusal to participate in the study
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Post-Pyloric Feeding Group
A nasoenteric tube (Nuritia, 10Fr) will be placed within 24 hours of admission.
The procedure involves elevating the head of the bed to approximately 30-45°, lubricating the tube with liquid paraffin, inserting it into the stomach using a blind insertion technique, then positioning the patient in the right lateral decubitus position.
The insertion length will be approximately 75 cm.
200-500 ml of air and warm water will be injected into the stomach to open the pylorus.
Gently, as the pylorus opens, the tube will be advanced beyond the ligament of Treitz.
Digestive fluid will be aspirated for pH testing.
Tube position (post-pyloric) will be confirmed by X-ray before initiating enteral nutrition support.
An appropriate nutritional formula will be selected based on the patient's condition.
The initial infusion rate will be 20 ml/h using a nutrition pump.
The head of the bed will be elevated to 30-45°.
Observation will occur continuously for the first hour, then every 4 hours.
The rate wi
|
A nasoenteric tube (Nuritia, 10Fr) will be placed within 24 hours of admission.
The procedure involves elevating the head of the bed to approximately 30-45°, lubricating the tube with liquid paraffin, inserting it into the stomach using a blind insertion technique, then positioning the patient in the right lateral decubitus position.
The insertion length will be approximately 75 cm.
200-500 ml of air and warm water will be injected into the stomach to open the pylorus.
Gently, as the pylorus opens, the tube will be advanced beyond the ligament of Treitz.
Digestive fluid will be aspirated for pH testing.
Tube position (post-pyloric) will be confirmed by X-ray before initiating enteral nutrition support.
An appropriate nutritional formula will be selected based on the patient's condition.
The initial infusion rate will be 20 ml/h using a nutrition pump.
The head of the bed will be elevated to 30-45°.
Observation will occur continuously for the first hour, then every 4 hours.
The rate wil
|
|
Aktiv komparator: Gastric Feeding Group
A nasogastric tube (Nuritia, 14Fr) will be placed within 24 hours of admission.
The tube will be lubricated with liquid paraffin, inserted into the gastric cavity using a blind insertion technique, and properly fixed.
Correct position will be confirmed by auscultation of air insufflation over the stomach before initiating enteral nutrition support.
An appropriate nutritional formula will be selected based on the patient's condition.
The initial infusion rate will be 20 ml/h using a nutrition pump.
The head of the bed will be elevated to 30-45°.
Observation will occur continuously for the first hour, then every 4 hours.
The rate will be gradually increased by 10 mL every 4 hours based on patient tolerance until the daily target volume (25-30 kcal/kg/day) is achieved.
|
A nasogastric tube (Nuritia, 14Fr) will be placed within 24 hours of admission.
The tube will be lubricated with liquid paraffin, inserted into the gastric cavity using a blind insertion technique, and properly fixed.
Correct position will be confirmed by auscultation of air insufflation over the stomach before initiating enteral nutrition support.
An appropriate nutritional formula will be selected based on the patient's condition.
The initial infusion rate will be 20 ml/h using a nutrition pump.
The head of the bed will be elevated to 30-45°.
Observation will occur continuously for the first hour, then every 4 hours.
The rate will be gradually increased by 10 mL every 4 hours based on patient tolerance until the daily target volume (25-30 kcal/kg/day) is achieved.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of stroke-associated pneumonia within 7 days of onset
Tidsramme: 7 days of onset.
|
The diagnostic criteria for SAP will follow the 2019 Chinese Expert Consensus on the Diagnosis and Treatment of Stroke-Associated Pneumonia.
|
7 days of onset.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hospital length of stay
Tidsramme: From date of admission to date of discharge, assessed up to 28 days
|
Length of patients stay in the hospital
|
From date of admission to date of discharge, assessed up to 28 days
|
|
90-day modified Rankin Scale (mRS) score
Tidsramme: 90 days after randomization
|
The distribution of the 90-day mRS (0;1;2;3;4;5;6) as assessed by structured assessment.
|
90 days after randomization
|
|
Time from admission to achieving enteral nutrition target
Tidsramme: From date of admission until enteral nutrition target is achieved, assessed up to 28 days
|
Enteral nutrition target is set as 25-30kcal/kg.
|
From date of admission until enteral nutrition target is achieved, assessed up to 28 days
|
|
Change from baseline in serum albumin level at Day 14
Tidsramme: Baseline and Day 14
|
Serum albumin will be measured via venous blood sample.
|
Baseline and Day 14
|
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Change from baseline in serum albumin level at Day 28
Tidsramme: Baseline and Day 28
|
Serum albumin will be measured via venous blood sample
|
Baseline and Day 28
|
|
Change from baseline in white blood cell count at Day 14
Tidsramme: Baseline and Day 14
|
White blood cell count will be measured via venous blood sample.
|
Baseline and Day 14
|
|
Change from baseline in white blood cell count at Day 28
Tidsramme: Baseline and Day 28
|
White blood cell count will be measured via venous blood sample.
|
Baseline and Day 28
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mortality within 28 days
Tidsramme: 28 days post-randomization.
|
Percentage of patients who die within 28 days post-randomization.
|
28 days post-randomization.
|
|
Incidence of Gastrointestinal Complications
Tidsramme: 28 days
|
Gastrointestinal bleeding, diarrhea, abdominal distension, constipation, vomiting.
|
28 days
|
|
Catheter-related Complications
Tidsramme: 28 days
|
Blockage, displacement, dislodgement
|
28 days
|
|
Change from baseline in serum total protein level at Day 14
Tidsramme: Baseline and Day 14
|
Serum total protein level will be measured via venous blood sample.
|
Baseline and Day 14
|
|
Change from baseline in serum prealbumin level at Day 14
Tidsramme: Baseline and Day 14
|
Serum prealbumin level will be measured via venous blood sample.
|
Baseline and Day 14
|
|
Change from baseline in serum transferrin level at Day 14
Tidsramme: Baseline and Day 14
|
Serum transferrin level will be measured via venous blood sample.
|
Baseline and Day 14
|
|
Change from baseline in serum total protein level at Day 28
Tidsramme: Baseline and Day 28
|
Serum total protein will be measured via venous blood sample
|
Baseline and Day 28
|
|
Change from baseline in serum prealbumin level at Day 28
Tidsramme: Baseline and Day 28
|
Serum prealbumin will be measured via venous blood sample
|
Baseline and Day 28
|
|
Change from baseline in serum transferrin level at Day 28
Tidsramme: Baseline and Day 28
|
Serum transferrin will be measured via venous blood sample
|
Baseline and Day 28
|
|
Change from baseline in C-reactive protein level at Day 14
Tidsramme: Baseline and Day 14
|
C-reactive protein will be measured via venous blood sample.
|
Baseline and Day 14
|
|
Change from baseline in interleukin-6 level at Day 14
Tidsramme: Baseline and Day 14
|
Interleukin-6 level will be measured via venous blood sample.
|
Baseline and Day 14
|
|
Change from baseline in body temperature at Day 14
Tidsramme: Baseline and Day 14
|
Body temperature will be recorded at 8:00 AM daily during the hospitalization.
|
Baseline and Day 14
|
|
Change from baseline in interleukin-6 level at Day 28
Tidsramme: Baseline and Day 28
|
Interleukin-6 level will be measured via venous blood sample.
|
Baseline and Day 28
|
|
Change from baseline in C-reactive protein level at Day 28
Tidsramme: Baseline and Day 28
|
C-reactive protein level will be measured via venous blood sample.
|
Baseline and Day 28
|
|
Change from baseline in body temperature at Day 28
Tidsramme: Baseline and Day 28
|
Body temperature will be recorded at 8:00 AM daily during the hospitalization.
|
Baseline and Day 28
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Wusheng Zhu, MD, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
15. juni 2026
Primær fullføring (Antatt)
16. juni 2027
Studiet fullført (Antatt)
15. september 2027
Datoer for studieregistrering
Først innsendt
27. mai 2026
Først innsendt som oppfylte QC-kriteriene
1. juni 2026
Først lagt ut (Faktiske)
5. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FEED-SAP
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Patient information will be de-identified
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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