Postoperative Complications
Conditions
Keywords
IV fluid, recovery, goal directed fluid replacement, improved patient recovery
Brief summary
A trial in which patients having open abdominal surgery are randomized to receive either crystalloids or colloids intraoperatively, guided by esophageal Doppler. The investigators test the primary hypothesis that goal-directed colloid administration during elective abdominal surgery decreases a composite of postoperative complications within 30 days of surgery.
Detailed description
Patients will be given 5-7 ml/kg of crystalloid (lactated Ringer's) in the immediate preoperative period, which will be followed by 4 ml/kg/h crystalloid for maintenance normalized to ideal body weight \[Men: Ideal Body Weight (in kilograms) = 52 kg + 1.9 kg for every 2.5 cm over 150 cm; Women: Ideal Body Weight (in kilograms) = 49 kg + 1.7 kg for every 2.5 cm over 150 cm\]. They will then be randomly assigned to additional volume replacement, guided by esophageal Doppler, to either lactated Ringer's solution of Voluven starch.
Interventions
DRUGCrystalloid
For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of LR will be given over a period of 5 minutes.
DRUGColloid
For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of Hydroxyethylstarch 6% 130/0.4 (Voluven®Fresenius-Kabi, Bad Homburg, Germany) will be given over a period of 5 minutes.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ASA Physical Status 1-3 * Body Mass Index \< 35 * Moderate risk elective abdominal surgical procedures scheduled to take ≥ two hours done under general anesthesia.
Exclusion criteria
* cardiac insufficiency (EF\<35%) * coronary disease with angina (NYHA IV) * severe chronic obstructive pulmonary disease * coagulopathies * symptoms of infection or sepsis * renal insufficiency (creatinine clearance \<30ml/min or renal replacement therapy) * ASA Physical Status \> 3.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative Morbidity (Major Complications) | Postoperative 30-days | Any of the following major complications: (1) Cardiac (Acute heart failure/Myocardial infarction/Ventricular arrhythmia); (2) pulmonary (embolism/edema/respiratory failure/pneumonia/pleural effusion); (3) gastrointestinal (bowel and surgical anastomosis stricture or anastomotic leak/internal or external fistulas/peritoneal effusions); (4) Renal (requiring dialysis); (5) Infectious (deep or organ space surgical site infection / sepsis); and (6) Coagulation (bleeding). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative Morbidity (Minor Complications) | Postoperative 30-days | Any of the following minor complications: (1) unplanned ICU admission; (2) unplanned operation; (3) cardiac (ischemia/non-ventricular arrhythmia/hemodynamic disturbances); (4) pulmonary effusion; (5) deep venous thrombosis; (6) gastrointestinal (effusion/gut paralysis); (7) progressive renal insufficiency; (8) infection (superficial/fever/cystitis or urinary tract infection); and (9) transient neurological injury. |
| Number of Participants With Postoperative Complications, 30-day Readmission, and 30-day Death | Postoperative 30 days | A composite of the primary outcome, and readmission and death. |
| Number of Participants With Postoperative Acute Kidney Injury | Hospitalization | Preoperative-to-postoperative change in AKIN stage |
Countries
Austria, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Crystalloid Lactated Ringers solution will be used for fluid replacement.
Crystalloid: For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of LR will be given over a period of 5 minutes. | 534 |
| Colloid Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement
Colloid: For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of Hydroxyethylstarch 6% 130/0.4 (Voluven®Fresenius-Kabi, Bad Homburg, Germany) will be given over a period of 5 minutes. | 523 |
| Total | 1,057 |
Baseline characteristics
| Characteristic | Crystalloid | Colloid | Total |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 16 | 52 years STANDARD_DEVIATION 16 | 52 years STANDARD_DEVIATION 16 |
| Sex: Female, Male Female | 268 Participants | 242 Participants | 510 Participants |
| Sex: Female, Male Male | 266 Participants | 281 Participants | 547 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 534 | 5 / 523 |
| other Total, other adverse events | 234 / 534 | 214 / 523 |
| serious Total, serious adverse events | 103 / 534 | 91 / 523 |
Outcome results
Primary
Number of Participants With Postoperative Morbidity (Major Complications)
Any of the following major complications: (1) Cardiac (Acute heart failure/Myocardial infarction/Ventricular arrhythmia); (2) pulmonary (embolism/edema/respiratory failure/pneumonia/pleural effusion); (3) gastrointestinal (bowel and surgical anastomosis stricture or anastomotic leak/internal or external fistulas/peritoneal effusions); (4) Renal (requiring dialysis); (5) Infectious (deep or organ space surgical site infection / sepsis); and (6) Coagulation (bleeding).
Time frame: Postoperative 30-days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crystalloid | Number of Participants With Postoperative Morbidity (Major Complications) | 103 Participants |
| Colloid | Number of Participants With Postoperative Morbidity (Major Complications) | 91 Participants |
p-value: 0.5195% CI: [0.65, 1.23]GEE model
Secondary
Number of Participants With Postoperative Acute Kidney Injury
Preoperative-to-postoperative change in AKIN stage
Time frame: Hospitalization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crystalloid | Number of Participants With Postoperative Acute Kidney Injury | 21 Participants |
| Colloid | Number of Participants With Postoperative Acute Kidney Injury | 16 Participants |
p-value: 0.495% CI: [0.69, 2.58]Chi-squared
Secondary
Number of Participants With Postoperative Complications, 30-day Readmission, and 30-day Death
A composite of the primary outcome, and readmission and death.
Time frame: Postoperative 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crystalloid | Number of Participants With Postoperative Complications, 30-day Readmission, and 30-day Death | 143 Participants |
| Colloid | Number of Participants With Postoperative Complications, 30-day Readmission, and 30-day Death | 125 Participants |
p-value: 0.2695% CI: [0.72, 1.09]Chi-squared
Secondary
Number of Participants With Postoperative Morbidity (Minor Complications)
Any of the following minor complications: (1) unplanned ICU admission; (2) unplanned operation; (3) cardiac (ischemia/non-ventricular arrhythmia/hemodynamic disturbances); (4) pulmonary effusion; (5) deep venous thrombosis; (6) gastrointestinal (effusion/gut paralysis); (7) progressive renal insufficiency; (8) infection (superficial/fever/cystitis or urinary tract infection); and (9) transient neurological injury.
Time frame: Postoperative 30-days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crystalloid | Number of Participants With Postoperative Morbidity (Minor Complications) | 234 Participants |
| Colloid | Number of Participants With Postoperative Morbidity (Minor Complications) | 214 Participants |
p-value: 0.4295% CI: [0.81, 1.11]Chi-squared