Impact of Early Enteral Feeding on Splanchnic Blood Flow After Surgery for Critical Heart Disease in the Newborn
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Neonates with critical congenital heart disease (CHD) undergoing surgery often have postoperative decreases in cardiac output. These hemodynamic changes can result in varying levels of organ dysfunction, ranging from the subclinical to the more overt. Although this low cardiac output syndrome (LCOS) and accompanying multiorgan dysfunction syndrome (MODS) is in large part transient, the rapidity and completeness of resolution can vary greatly.
During postoperative care in the intensive care unit, knowledge of this phenomenon must be balanced against the desire to initiate enteral nutrition. Many studies have demonstrated that timely initiation of enteral feeds in the intensive care can reduce mortality, morbidity and costs. Practically speaking, the decision to initiate feeds is made based on the patient's postoperative hemodynamic status, a normal lactate, absence of vasopressor agents and presence of bowel sounds. Trophic enteral feeding can usually commence 24h postoperatively, even after complicated neonatal heart surgery,
The vast majority of postoperative neonates suffer no apparent ill effects from this management strategy. However, recent data have demonstrated an exceedingly high incidence (3.3-6.8%) of necrotizing enterocolitis (NEC) in CHD patients; a disease for which diminution in splanchnic blood flow and disruption of the mucosal barrier are felt to play an important role. These data suggest the combination of diminished cardiovascular reserve, cyanosis and increased myocardial oxygen demands may promote the development of NEC.
Preliminary data from Sickkids (Chanthong and Sivarajan, 2008) demonstrates an NEC incidence of 8% in CHD patients. Patients with NEC also accounted for 25% of all cardiac arrests in Cardiac CCU.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Ontario
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Toronto, Ontario, Kanada, M5G 1X8
- The Hospital for Sick Children
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- neonates ≤ 30 days of postnatal age at time of operation
- birthweight > 2.5 kg
- gestational age at birth ≥ 35 weeks
- Patients requiring cardiac surgery who are expected to remain intubated in the CCIU for > 48 hours
- informed consent by parent or guardian
- approval by treating critical care staff physician
Exclusion Criteria:
- patients with heterotaxy or pre-existing renal or abdominal pathology (eg. preoperative diagnosis of NEC).
- need for ECMO after repair within the study period (data up to that point will be recorded and analyzed).
- Parent refusal of formula for purposes of study
- Patient on vasopressin or norepinephrine infusion
- Parent or legal guardian refuse consent
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 1
The initial observation period of the study begins in the postoperative period (time 0) after the patient arrives in the Cardiac Critical Care Unit and calibration of the monitors with initial clinically indicated baseline bloodwork is completed.
Eligible patients will be randomized when the clinical decision to feed is made (by the treating team) to one of the two treatment arms.
Patients in arm 1 will receive continuous nasogastric formula feeding at time 1 and NPO at time 2 (12 hours later).
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Continuous nasogastric formula feeding (using Enfalac with iron 2400 kJ/L at a volume of 1ml/kg/h) at time 1 and NPO at time 2 (12 hours later)
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|
Experimentell: 2
The initial observation period of the study begins in the postoperative period (time 0) after the patient arrives in the Cardiac Critical Care Unit and calibration of the monitors with initial clinically indicated baseline bloodwork is completed.
Eligible patients will be randomized when the clinical decision to feed is made (by the treating team) to one of the two treatment arms.
Patients in arm 2 will receive NPO at time 1 and crossover to continuous nasogastric formula feeding at time 2.
|
NPO at time 1 and continuous nasogastric formula feeding (using Enfalac with iron 2400 kJ/L at a volume of 1ml/kg/h) at time 2 (12 hours later).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Change in ultrasound derived bloodflow in superior mesenteric artery after feeding by 1 SD from prefeeding value.
Tidsram: At 0, 6, 12 and 24 hours after arrival at CCU; At 12 and 24 hours after decision to feed is made
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At 0, 6, 12 and 24 hours after arrival at CCU; At 12 and 24 hours after decision to feed is made
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Impact of Feeding on: Cardiac Output as measured by continuous mass spectometry, Fractional splanchnic output, Renal Perfusion, Tonometric, Assessment of gastric mucosal pH e. Cerebral oxygen delivery using the NIRS probe
Tidsram: Duration of patient's participation in the study
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Duration of patient's participation in the study
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Correlation and Agreement between: Echo and continuous cardiac output measures; gastric tonometry, SMA PSV and qualitative Bowel Perfusion Index; renal artery PSV and temporal urine output
Tidsram: Duration of patient's participation in the study
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Duration of patient's participation in the study
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Patient Outcomes: Survival, Time to Extubation, Duration of Postop ICU Admission, Duration of Postop hospital Admission, Discharge weight, Number of Nosocomial Infections, Development of NEC
Tidsram: Duration of patient's [articipation in the study
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Duration of patient's [articipation in the study
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ben Sivarajan, MD, The Hospital for Sick Children
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1000012584
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