Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273377
Status:
COMPLETED
Last Update Posted:
2016-06-29
First Post:
2006-01-05
Brief Title:
The Effects of Hypercapnia Supplemental Oxygen and Dexamethasone on Surgical Wound Infection
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
The Effects of Hypercapnia Supplemental Oxygen and Dexamethasone on Surgical Wound Infection
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators will test the hypotheses that mild hypercapnia and supplemental oxygen reduce wound infection risk in patients undergoing colon resection The investigators will simultaneously test the hypothesis that low-dose dexamethasone a common treatment for postoperative nausea and vomiting does not increase infection risk
Detailed Description:
Wound infections are common and serious complications of anesthesia and surgery Even in patients who are kept normothermic and given supplemental oxygen the incidence of wound infection after colon resection exceeds 5 About 80 of these resections are done for colon cancer the third leading cause of cancer death The average surgical wound infection prolongs hospitalization by a week and substantially increases cost Major factors influencing the incidence of surgical wound infection include the site and complexity of surgery underlying illness including treatment with immunosuppressive drugs timely administration of prophylactic antibiotics intraoperative patient temperature hypovolemia and tissue oxygen tension
The primary defense against surgical pathogens is oxidative killing by neutrophils Oxygen is a substrate for this process and the reaction critically depends on tissue oxygen tension throughout the observed physiological range It is therefore unsurprising that subcutaneous tissue oxygen tension PsqO2 is inversely correlated with the risk of surgical wound infection Primary determinants of tissue oxygen availability include arterial oxygen tension hemoglobin concentration and local perfusion
An additional determinant of peripheral oxygen delivery is cardiac output Mild hypercapnia increases cardiac output for example augmenting arterial carbon dioxide tension PaCO2 just 10-12 mmHg increases the cardiac index 15 Our preliminary studies confirm that mild hypercapnia increases cardiac output and additionally indicate the hypercapnia markedly improves tissue oxygenation For example tissue oxygen tension increased 16 mmHg from 58 to 74 mmHg over a 20 mmHg range of PaCO2 in anesthetized volunteers We have also shown that increasing PaCO2 by just 15 mmHg increased tissue oxygen tension 16 mmHg in surgical patients Similar results were observed in morbidly obese patients Previous work indicates that similar increases in PsqO2 reduces the risk of surgical wound infection by about 30 We thus propose to test the hypothesis that mild hypercapnia significantly reduces the incidence of surgical wound infection in normothermic patients undergoing colon resection Secondary outcomes will include the duration of hospitalization cost of care the incidence of nosocomial pneumonia the incidence of postoperative nausea and vomiting PONV and return to function
High intra- and postoperative oxygen concentration 80 as opposed to 30 oxygen has been shown to reduce the rate of wound infection by more than 50 Therefore the protocol implemented high intraoperative oxygen concentrations for all patients this trial However within the first 500 enrolled patients a recent trial reported a better outcome for patients with low perioperative oxygen concentrations Although that trial was less well controlled and underpowered the conflicting evidence indicates that additional study is needed We will therefore simultaneously test the hypothesis that supplemental oxygen reduces infection risk
Patients undergoing colon surgery are generally at high risk for postoperative nausea and vomiting PONV According to results from meta-analyses a single intraoperative dose of dexamethasone is effective and safe for the prophylaxis for PONV Dexamethasone has thus been recommended as a first-line prophylaxis for PONV However none of the previous PONV trials have focused on wound infections nor had a sufficiently long observational period to rule out potential concerns of an increased incidence of wound infection We will therefore also test the hypothesis that dexamethasone does not increase the risk of surgical wound infection The second and third hypotheses will be added to the protocol using a factorial design after the first 500 patients are enrolled
The primary defense against surgical pathogens is oxidative killing by neutrophils Oxygen is a substrate for this process and the reaction critically depends on tissue oxygen tension throughout the observed physiological range It is therefore unsurprising that subcutaneous tissue oxygen tension PsqO2 is inversely correlated with the risk of surgical wound infection Primary determinants of tissue oxygen availability include arterial oxygen tension hemoglobin concentration and local perfusion
An additional determinant of peripheral oxygen delivery is cardiac output Mild hypercapnia increases cardiac output for example augmenting arterial carbon dioxide tension PaCO2 just 10-12 mmHg increases the cardiac index 15 Our preliminary studies confirm that mild hypercapnia increases cardiac output and additionally indicate the hypercapnia markedly improves tissue oxygenation For example tissue oxygen tension increased 16 mmHg from 58 to 74 mmHg over a 20 mmHg range of PaCO2 in anesthetized volunteers We have also shown that increasing PaCO2 by just 15 mmHg increased tissue oxygen tension 16 mmHg in surgical patients Similar results were observed in morbidly obese patients Previous work indicates that similar increases in PsqO2 reduces the risk of surgical wound infection by about 30 We thus propose to test the hypothesis that mild hypercapnia significantly reduces the incidence of surgical wound infection in normothermic patients undergoing colon resection Secondary outcomes will include the duration of hospitalization cost of care the incidence of nosocomial pneumonia the incidence of postoperative nausea and vomiting PONV and return to function
High intra- and postoperative oxygen concentration 80 as opposed to 30 oxygen has been shown to reduce the rate of wound infection by more than 50 Therefore the protocol implemented high intraoperative oxygen concentrations for all patients this trial However within the first 500 enrolled patients a recent trial reported a better outcome for patients with low perioperative oxygen concentrations Although that trial was less well controlled and underpowered the conflicting evidence indicates that additional study is needed We will therefore simultaneously test the hypothesis that supplemental oxygen reduces infection risk
Patients undergoing colon surgery are generally at high risk for postoperative nausea and vomiting PONV According to results from meta-analyses a single intraoperative dose of dexamethasone is effective and safe for the prophylaxis for PONV Dexamethasone has thus been recommended as a first-line prophylaxis for PONV However none of the previous PONV trials have focused on wound infections nor had a sufficiently long observational period to rule out potential concerns of an increased incidence of wound infection We will therefore also test the hypothesis that dexamethasone does not increase the risk of surgical wound infection The second and third hypotheses will be added to the protocol using a factorial design after the first 500 patients are enrolled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH Grant GM 061655 | None | None | None |
| Gheens Foundation | None | None | None |
| Joseph Drown Foundation | None | None | None |