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The efficacy and safety of intestinal microbiota transplantation with high-risk drug-resistant pneumonia in ICU

The efficacy and safety of intestinal microbiota transplantation with high-risk drug-resistant pneumonia in ICU

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022915
Enrollment
Unknown
Registered
2019-05-02
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pneumonia

Interventions

Experimental group:IMT
Control group:Normal saline

Sponsors

Zhongshan Hospital Affiliated to Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: The score of APPACHEII was more than 9, and it met any of the following 3 points: 1. The patient had a clear history of drug-resistant bacterial infection (or colonization) within 3 months before admission; 2. Conform to 3 or more high-risk factor of drug-resistant bacteria infection;2. More than 3 repeated admissions due to infection within half a year before admission.

Exclusion criteria

Exclusion criteria: A. Less than 18 years old or over 75 years old; B. The history of total gastrectomy, partial gastrectomy, intrathoracic stomach, cholecystectomy, appendectomy and CRC tumor; C. =III°lumbosacral bedsore or perianal surgery history; D. Intestinal obstruction, intestinal perforation and gastrointestinal bleeding (except for OB positive stool); E. Hemodynamic instability: refers to the shock patients who, 48 hours after active fluid resuscitation and vasoactive drug treatment, still have one of the following characteristics: 1.2. The use of vasoactive drugs cannot be reduced; 3. Lactate clearance rate (Max - min/Max x100% within 48h upon admission) was less than 50%. F. Severe cardiac insufficiency (meet one of the following: 1. The NYHA heart function class IV; 2. There are serious heart valve disease cardiac function III level;3. Cardiac ultrasound examination for heart failure due to any reason (EF 30%); G. Hepatic insufficiency: ( 1.hepatic encephalopathy; 2. Cirrhosis liver function child-pugh grade C); H. For patients with chronic renal insufficiency: formula for ckd-epi (chronic renal disease epidemiology group) with glomerular filtration rate less than 30ml/min (NKF) : eGFR = a (serum creatinine/b)c (0.993) age; (a values were calculated by gender and race as follows: black: female = 166; Male = 163 white and other female = 144; Male = 141; B values were respectively used as follows according to gender: female = 0.7; Male = 0.9; C values were calculated according to age and serum creatinine value (rosh enzyme), using the following values: female serum creatinine 0.7mg /dL = -0.329, serum creatinine > 0.7mg /dL = -1.209.Male serum creatinine 0.7mg /dL = -0.411, serum creatinine > 0.7mg /dL = -1.209. Note: acute renal failure was not considered. I. Chronic respiratory insufficiency: meet one of the following: 1. Respiratory function failure cause for chronic restrictive lung disease or lung fibrosis merger activity endurance of NYHA cardiac function class IV; 2. Patients with end-stage chronic respiratory failure whose expected survival time is less than 28 days. G. Those who have used probiotics and probiotics in the recent 1 month; K. Pregnant and lactating women; L, Apache-ii grades 30 and/or AGI grades 4; M, Advanced tumor, malignant fluid; N. Rejected by the patient or family members.

Design outcomes

Primary

MeasureTime frame
ICU days;

Countries

China

Contacts

Public ContactLiu Huiheng

Emergency Department of Zhongshan Hospital Affiliated to Xiamen University

lena_8888666@163.com+86 13779950636

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026