Early Metabolic Support as a Potential Solution to Multi-Organ Dysfunction Syndrome (MODS) During Severe Sepsis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Feasibility of Early Metabolic Support in Participants with Sepsis Determined by Adherence
研究概览
简要总结
The goal of this clinical research study is to learn if adding liquid nutrition therapy that is given by vein to standard-of-care treatment for sepsis can help to control sepsis symptoms better than giving standard-of-care treatment alone.
Researchers also want to compare the length of ICU and hospital stay and any side effects between these 2 treatments.
详细描述
Study Groups and Procedures:
If participant is eligible and chooses to take part in this study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
Group 1 will receive standard-of-care treatment alone for up to 7 days.
Group 2 will receive standard treatment for up to 7 days, plus liquid nutrition. The liquid nutrition will be given by vein non-stop for up to 7 days. The liquid nutrition therapy may stop sooner if participant's doctor thinks they are ready, based on how they are tolerating tube feeding.
Both Groups: As part of standard treatment, participants will receive breathing and blood pressure support, daily routine blood draws, imaging, standard drugs (such as antibiotics and blood pressure drugs), and other tests the doctor decides are needed. These tests and treatment will begin within 12 hours after participant is admitted to the ICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients 18-years-old or greater
- •Admitted to the adult medical intensive unit (MICU) of MD Anderson Cancer Center
- •Diagnosis of Sepsis within 12 hours of MICU admission defined as: 1) Suspected or documented infection and 2) Acute increase of >/= 2 SOFA points (a proxy for organ dysfunction)
- •Diagnosis of Septic Shock within 12 hours of MICU admission defined as meeting criteria for sepsis (see inclusion criteria C) in addition to the following: 1) Vasopressor therapy needed to elevate MAP >/= 65 mmg Hg and 2) Lactate > 2 mmol/L (18 mg/dL) after adequate fluid resuscitation
- •Sequential Organ Failure Assessment (SOFA) score meeting the following requirements: 1) Cardiovascular SOFA >/= 2 and 2) Total SOFA score of less than 15
- •Diagnosis of leukemia, lymphoma, or status post stem cell transplantation
- •Patients in septic shock and not able to tolerate enteral nutrition above 70 percent of their daily nutritional caloric intake.
排除标准
- •1. Children (patients \< 18-years-old) of age are not admitted to the MICU but to the pediatric intensive care unit (PICU)
- •2. Do Not Resuscitate (DNR), Comfort Care or Moribund
- •3. Death expected within the next 24 hours
- •4. Active Bleeding
- •5. End-stage Renal Disease (ESRD)
- •6. Chronic Liver Disease: Childs-Pugh Class C and/or Diagnosis of Cirrhosis
- •7. Tumor Lysis Syndrome
- •8. Sulfite Allergy: Hepatamine contraindicated. More common in asthmatics. (Please note that this is NOT sulfa allergy and is NOT contraindicated in patients with sulfa allergy)
- •9. Serum sodium concentration \< 130 milliequivalent (mEq)/L or \>150 mEq/L (Note: Once serum sodium levels are \>/= 130 or \ 2.5 mg/dL (Note: Once serum creatinine levels are =/\< 2.5 mg/dL within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction.)
- •11. 11) Urine output \< 400 cc/24hrs (Note: Once urine output levels are \>/= 400 cc within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction.)
- •12. Hyperkalemia K \> 5.5 mEq/L (Note: Once potassium levels are \ 250 mg/dL (Note: Once glucose is \ 8.0 mg/dL
- •15. Patient with a history of metabolic abnormality in any one of the following amino acids: Alanine, Arginine, Cysteine hydrochloride, Glycine, Histidine, Isoleucine, Leucine, Lysine acetate, Methionine, Phenylalanine, Phosphoric ac-id, Proline, Serine, Threonine, Tryptophan, and Valine.
研究组 & 干预措施
Standard-of-Care Treatment for Sepsis
Participants with diagnosis of septic shock in MD Anderson Cancer Center ICU receive standard of care treatment alone for up to 7 days.
干预措施: Insulin Drip (Procedure)
Standard-of-Care Treatment Plus Liquid Nutrition for Sepsis
Participants with diagnosis of septic shock in MD Anderson Cancer Center ICU receive standard of care treatment plus plus liquid nutrition for up to 7 days.
干预措施: Liquid Nutrition (Dietary Supplement)
Standard-of-Care Treatment Plus Liquid Nutrition for Sepsis
Participants with diagnosis of septic shock in MD Anderson Cancer Center ICU receive standard of care treatment plus plus liquid nutrition for up to 7 days.
干预措施: Insulin Drip (Procedure)
结局指标
主要结局
Feasibility of Early Metabolic Support in Participants with Sepsis Determined by Adherence
时间窗: 7 days
Trial feasible if ≥ 60% of enrolled patients complete the treatments up to 7 days or upon discharge from the ICU, whichever comes first.
Feasibility of Early Metabolic Support in Participants with Sepsis Determined by Accrual
时间窗: 7 days
Trial feasible if ≥ 50% of eligible patients consent (i.e., approach 100 patients to achieve 50 that consent).
次要结局
未报告次要终点