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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crystalloid | Active Comparator | Lactated Ringers solution will be used for fluid replacement. |
|
| Colloid | Active Comparator | Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crystalloid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Postoperative 30-days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Kurz, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States | ||
| Cleveland Clinic Hillcrest Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32753064 | Derived | Reiterer C, Kabon B, Taschner A, Zotti O, Kurz A, Fleischmann E. A comparison of intraoperative goal-directed intravenous administration of crystalloid versus colloid solutions on the postoperative maximum N-terminal pro brain natriuretic peptide in patients undergoing moderate- to high-risk noncardiac surgery. BMC Anesthesiol. 2020 Aug 4;20(1):192. doi: 10.1186/s12871-020-01104-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | Postoperative 30-days |
|
30-days postoperative
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms did not be recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac | Cardiac disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor unplanned operation | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel I. Sessler, MD | Cleveland Clinic | 216-444-4900 | DS@OR.org |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D000077325 | Ringer's Lactate |
| D003102 | Colloids |
| C485123 | HES 130-0.4 |
| ID | Term |
|---|---|
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045424 | Complex Mixtures |
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|
|
| Colloid | Drug | 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. |
|
|
| Postoperative 30-days |
| Number of Participants With Postoperative Complications, 30-day Readmission, and 30-day Death | A composite of the primary outcome, and readmission and death. | Postoperative 30 days |
| Number of Participants With Postoperative Acute Kidney Injury | Preoperative-to-postoperative change in AKIN stage | Hospitalization |
| Mayfield Heights |
| Ohio |
| 44124 |
| United States |
| Medical University of Vienna | Vienna | 1090 | Austria |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| 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. | Posted | Count of Participants | Participants | Postoperative 30-days |
|
|
|
|
| Secondary | Number of Participants With Postoperative Complications, 30-day Readmission, and 30-day Death | A composite of the primary outcome, and readmission and death. | Posted | Count of Participants | Participants | Postoperative 30 days |
|
|
|
|
| Secondary | Number of Participants With Postoperative Acute Kidney Injury | Preoperative-to-postoperative change in AKIN stage | Posted | Count of Participants | Participants | Hospitalization |
|
|
|
|
| 4 |
| 534 |
| 103 |
| 534 |
| 234 |
| 534 |
| EG001 | 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. | 5 | 523 | 91 | 523 | 214 | 523 |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
|
| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment |
|
|
| Renal | Renal and urinary disorders | Non-systematic Assessment | - Requiring dialysis |
|
| infections | Infections and infestations | Non-systematic Assessment |
|
|
| Coagulation | Vascular disorders | Non-systematic Assessment | Bleeding |
|
| Cardiac | Cardiac disorders | Non-systematic Assessment |
|
|
| Pulmonary effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment |
|
|
| Infection | Infections and infestations | Non-systematic Assessment | Infection
|
|
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| D004304 |
| Dosage Forms |