Table 3 Top ten study proposals for future research on GI dysfunction (what we need to know)
Final rank and acronym | Research questions/aims | Study design | Study population | Indicator/Intervention | Suggested outcome variables | Points |
|---|---|---|---|---|---|---|
1. Diarrhoea prevention | Does routine use of fibre-enriched EN reduce diarrhoea? | RCT | Critically ill patients with EN with a standard protocol | Fibre-enriched vs non-fibre EN | Bristol stool chart GI symptoms* | 400 |
2. Opioid antagonists for bowel paralysis | Do opioid antagonists reduce time to defaecation and GI symptoms? Potential substudy: study the impact on intestinal absorption | Multicentre RCT | Adult ICU patients with opioid requirement above a minimal dosage | Methylnaltrexone (or other opioid antagonists) vs placebo | Time to the first defaecation COS# GI symptoms* Infections Substudy: absorption | 373 |
3. Diarrhoea management | Does reduction or discontinuation of EN reduce diarrhoea? | RCT (3-armed study) | Patients with severe diarrhoea during EN Severe diarrhoea = requiring interventions (fluids and electrolytes). | 1. Continuation of EN 2. Reduction of EN (50%) 3. Trophic EN + supplemental PN (after 3–7 days) | Bristol stool chart GI symptoms* LOS infections | 343 |
4. Prophylaxis vs treatment of upper GI intolerance | Is the prophylactic use of prokinetics superior to therapeutic use? | Multicentre RCT | Adult ICU patients at high risk for gastroparesis (e.g. patients with high doses of opioids, post-GI surgery) | Two study arms, the same drugs (e.g. erythromycin, metoclopramide, alizapride) and dosages, different timing (routine administration or only in confirmed gastroparesis) | COS# safety outcomes Long-term outcomes (prolonged QT, extrapyramidal side effects, colonization with multi-resistant microbes) | 335 |
5. Prophylaxis vs treatment of lower GI intolerance | Does the prophylactic use of motility agents (prokinetics and laxative drugs) reduce time to defaecation and improve feeding tolerance and GI dysfunction based on AGI grading? | Multicentre RCT | Adult consecutive ICU patients with an expected ICU stay of ≥ 3 days? | Two study arms, the same drugs (e.g. macrogol, laxatives) and dosages, different timing (routine administration or only in confirmed constipation/bowel paralysis) | Time to defaecation AGI dynamics COS (clinical outcomes) Infections Diarrhoea Mesenteric ischaemia | 323 |
6. IAH-GI + NOMI-AGI | 1. Does protocolised monitoring of IAP and management of IAH improve outcome? 2. Is increased IAP associated with GI dysmotility? | 1. RCT 2. Observational substudy | MV patients at risk of IAH | Intervention: monitoring and management of IAP based on the protocol (bundle of preventive measures) Control: standard care US in the intervention group | Mesenteric ischaemia Incidence of infections/sepsis Mortality 90 days, LOS, GI symptoms* Obervational substudy: correlation between IAP and GI motility as assessed by US | 312 |
7. Indication of post-pyloric feeding | Is post-pyloric feeding superior to PN in case of gastroparesis? | Multicentre RCT | Adult ICU patients with gastroparesis (e.g. GRV > 500 mL with prokinetics) | Post-pyloric feeding vs PN | Infections Mortality GI complications (including non-occlusive bowel ischaemia), meeting nutritional target | 290 |
8. GI and IAP | Which GI symptoms* should trigger IAP measurements? Which IAP values should trigger specific monitoring of GI? | Post hoc analysis of combined databases (prospective observational) | Patients in performed studies | Identification and merging of existing databases | Association of GI symptoms with IAH, mesenteric ischaemia and mortality | 274 |
9. AGI prospective | Does AGI score (AGI I–IV) predict the outcome? | Prospective observational | Consecutive ICU patients being mechanically ventilated for non-elective reason (planned MV after elective surgery excluded) | AGI score documented daily Decisions for diagnostics or treatment taken based on daily assessed GI symptoms* documented daily Preferably similar feeding protocol in all centres | GI symptoms* Pneumonia COS# ICU outcome 90-day outcome Long-term patient-centred outcome NOBN GI anastomosis leakage (if relevant) | 272 |
10. PPI and dysbiosis | Does use of PPI vs no PPI alters the intestinal microbiome? | RCT | Mech. ventilated ICU patients in need of EN and without an absolute indication for PPI | PPI vs no PPI | Faecal microbiome pattern Incidence of Clostridium difficile colitis | 249 |