Pulmonary EdemaNCT00995228
Fluid Management in the Post-Anesthetic Care Unit (PACU) at Sourasky Medical Center
An observational study of Pulmonary Edema and Acute Lung Injury, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Peri-operative fluid therapy is a controversial area with few randomized trials to guide practice. Fluid management has a significant influence on outcome following surgery. Yet practically, fluid prescription practice during this period is sub-optimal, resulting in avoidable iatrogenic complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Edema, Acute Lung Injury, Hypertension
- How many people
- 1,000 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients from both sexes >18 y/o, undergoing elective general or orthopedic surgery
Who may be able to join
- Men and women > 18 years old
- ASA I-III
- Undergoing elective general or orthopedic surgery
Who cannot join
- Emergency procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Practice of Fluid Management in the Post-anesthetic Care Unit (PACU) in Patients Undergoing Elective Surgery: an Observational Study
Peri-operative fluid therapy is a controversial area with few randomized trials to guide practice. Fluid management has a significant influence on outcome following surgery. Yet practically, fluid prescription practice during this period is sub-optimal, resulting in avoidable iatrogenic complications.
Several studies have assessed the effect of a 'liberal' vs. a 'restrictive' perioperative fluid regimen on post-operative outcome. However, most of these studies have focused primarily on intra-operative fluid management, whereas postoperative strategies have been less well defined, even though the immediate postoperative period is of critical importance to the patient's recovery. Moreover, whereas intra-operative fluid administration is monitored by the anesthesiologist, postoperatively it is less supervised and may result in excess or lack of intravenous (IV) fluids. Therefore, fluid management audit at the post-anesthesia care unit (PACU) is of paramount importance for patient healthcare. The objective of this study is to follow and report the current practice of fluid administration in the PACU of Tel Aviv Sourasky Medical Center, for an extended period of time as a first step towards establishing evidence-based guidelines for postoperative fluid management.
Read the detailed description
Background
Perioperative intravenous (IV) fluid management has been a historically controversial issue in anesthesiology. Accumulating evidence suggest that regulated perioperative fluid management has beneficial effects on postoperative outcomes. A restricted perioperative IV fluid regimen aiming at unchanged body weight resulted in reduced complications after elective colorectal resection (1). In another study, patients receiving a reduced intraoperative fluid volume demonstrated less postoperative complications, lower morbidity rates and shorter hospital stay after intraabdominal surgery (2). Conversely, whereas restricted postoperative IV salt and water intake shortened gastrointestinal (GI) function and hospitalization after colonic resection in one study (3), it had no effect on the same outcomes in another randomized clinical trial (4).
Despite the reported benefits of restrictive fluid therapy, this strategy may be associated with adverse outcomes. Inadequate fluid administration can lead to a reduced effective circulating volume resulting in inefficient tissue perfusion (5-7). On the other hand, overhydration, resulting from perioperative fluid excess, has shown association with deleterious effects on cardiac and pulmonary function (8-12), and on recovery of GI motility (2,3,13), tissue oxygenation (14), wound healing and coagulation (15-16). Erroneous fluid administration is generally associated with increased morbidity and postoperative complications (17-21). Altogether, these observations call for a standardized and regulated fluid therapy throughout the perioperative period taking into account patients' premorbid diseases and type of surgery.
Previous studies have focused primarily on intra-operative fluid management. Postoperative strategies have been less well defined, even though the immediate postoperative period is of critical importance to the patient's recovery. Moreover, whereas intra-operative fluid administration is monitored by the anesthesiologist, postoperatively it is less supervised and may result in excess or lack of IV fluids.
The aim of this study is thus to follow and present the current practice of fluid administration in the PACU of Tel Aviv Sourasky Medical Center, for an extended period of time as a first step towards establishing evidence-based guidelines for postoperative fluid management.
Methods
We will collect data regarding intra- and postoperative fluid administration from the charts of >18 years old ASA I-III patients undergoing elective general or orthopedic surgery. Patients with renal/cardiac failure will be analyzed separately, since their pathology dictates extra caution with fluid therapy. Patients demographics, type of surgery, and the type and volume of fluids given during the operation and PACU stay, will be documented as well as the occurrence of morbidity in PACU, without any interventions. Data collection will be anonymous and will last six months. The setting will be the PACU of the Tal Aviv Sourasky Medical center.
Suggested benefits
The purpose of this data report is to provide an overview on the current practice of fluid management in Tel Aviv Sourasky Medical Center's PACU. We believe that this is a preliminary necessary step towards establishing guidelines for postoperative fluid management.
Study Objective
To describe the contemporary practice of postoperative fluid management in the PACU of the Sourasky Medical Center.
References
- Brandstrup B, Tonnesen H, Pott F et al (2003). Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg 238:641-8.
- Nisanevich V, Felsenstein I, Matot I, et al (2005). Effect of intraoperative fluid management on outcome after intraabdominal surgery.Anesthesiology.103:25-32.
- Lobo DN, Bostock KA, Allison SP, et al (2002). Effect of salt and water balance on recovery of gastrointestinal function after elective colonic resection: a randomised controlled trial. Lancet 359:1812-8.
- MacKay G, Fearon K, O'Dwyer PJ et al (2006). Randomized clinical trial of the effect of postoperative intravenous fluid restriction on recovery after elective colorectal surgery. Br J Surg 93:1469-74.
- Arkilic CF, Taguchi A, Sharma N, et al (2003). Supplemental perioperative fluid administration increases tissue oxygen pressure. Surgery 133:49-55.
- Bennett-Guerrero E, Welsby I, Dunn TJ, et al (1999). The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg 89:514-9.
- Mythen MG, Webb AR (1995). Perioperative plasma volume expansion reduces the incidence of gut mucosal hypoperfusion during cardiac surgery. Arch Surg 130:423-9.
- Arieff AI (1999). Fatal postoperative pulmonary edema: pathogenesis and literature review. Chest 115: 1371-77.
- Turnage WS, Lunn JJ (1993). Postpneumonectomy pulmonary edema. A retrospective analysis of associated variables. Chest. 103:1646-50.
- Mathru M, Blakeman BP (1993). Don't drown the "down lung". Chest 103:1644-5.
- Jordan S, Mitchell JA, Quinlan GJ, Goldstraw P, Evans TW. The pathogenesis of lung injury following pulmonary resection. Eur Respir J 2000; 15: 790-9
- Patel RL, Townsend ER, Fountain SW (1992). Elective pneumonectomy: factors associated with morbidity and operative mortality. Ann Thorac Surg 54: 84-8
- Prien T, Backhaus N, Pelster F, Pircher W, Bunte H, Lawin P (1990). Effect of intraoperative fluid administration and colloid osmotic pressure on the formation of intestinal edema during gastrointestinal surgery. J Clin Anesth 2: 317-23
- Heughan C, Ninikoski J, Hunt TK (1972). Effect of excessive infusion of saline solution on tissue oxygen transport. Surg Gynecol Obstet 135: 257-60
- Janvrin SB, Davies G, Greenhalgh RM (1980). Postoperative deep vein thrombosis caused by intravenous fluids during surgery. Br J Surg. 67:690-3
- Hartmann M, Jönsson K, Zederfeldt B (1992). Effect of tissue perfusion and oxygenation on accumulation of collagen in healing wounds. Randomized study in patients after major abdominal operations. Eur J Surg 158:521-6.
- Mutoh T, Lamm WJ, Embree LJ, Hildebrandt J, Albert RK (1992). Volume infusion produces abdominal distension, lung compression, and chest wall stiffening in pigs. J Appl Physiol 72: 575-82
- Ratner LE, Smith GW (1993). Intraoperative fluid management. Surg Clin North Am 73: 229-41
- Moore FD, Shires G (1967). Moderation. Ann Surg 166:300-1.
- Alsous F, Khamiees M, Manthous CA, et al (2000). Negative fluid balance predicts survival in patients with septic shock: a retrospective pilot study. Chest 117: 1749-54.
- Callum KG, Gray AJG, Hoile RW, et al (1999) Extremes of age: the 1999 report of the national confidential enquiry into perioperative deaths. London: National Confidential Enquiry into Perioperative Deaths.
- Conditions
- Pulmonary Edema, Acute Lung Injury, Hypertension, Renal Failure
- Keywords
- overhydration, fluid restriction, post-anesthesia care unit
- Medical subject headings
- Pulmonary Edema, Acute Lung Injury, Hypertension, Renal Insufficiency, Water Intoxication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EdemaStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Idit Matot, MD, Study chair, Department of Anesthesia and intensive care, Tel Aviv Sourasky Medical CenterYifat Klein, PhD, Principal investigator, Department of Anesthesia and intensive care, Tel Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995228
- Sponsor's protocol ID
- TASMC-09-IM-0501-CTIL
- Status last verified
- Oct 2009
- First submitted
- 14 Oct 2009
- Last updated
- 15 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Practice of Fluid Management in the Post-anesthetic Care Unit (PACU) in Patients Undergoing Elective Surgery: an Observational Study
- ClinicalTrials.gov ID
- NCT00995228
- Acronym / sponsor ID
- TASMC-09-IM-0501-CTIL
- Conditions
- Pulmonary Edema, Acute Lung Injury, Hypertension, Renal Failure
- Keywords
- overhydration, fluid restriction, post-anesthesia care unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Mar 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 15 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peri-operative fluid therapy is a controversial area with few randomized trials to guide practice. Fluid management has a significant influence on outcome following surgery. Yet practically, fluid prescription practice during this period is sub-optimal, resulting in avoidable iatrogenic complications.
Several studies have assessed the effect of a 'liberal' vs. a 'restrictive' perioperative fluid regimen on post-operative outcome. However, most of these studies have focused primarily on intra-operative fluid management, whereas postoperative strategies have been less well defined, even though the immediate postoperative period is of critical importance to the patient's recovery. Moreover, whereas intra-operative fluid administration is monitored by the anesthesiologist, postoperatively it is less supervised and may result in excess or lack of intravenous (IV) fluids. Therefore, fluid management audit at the post-anesthesia care unit (PACU) is of paramount importance for patient healthcare. The objective of this study is to follow and report the current practice of fluid administration in the PACU of Tel Aviv Sourasky Medical Center, for an extended period of time as a first step towards establishing evidence-based guidelines for postoperative fluid management.
Detailed description
Background
Perioperative intravenous (IV) fluid management has been a historically controversial issue in anesthesiology. Accumulating evidence suggest that regulated perioperative fluid management has beneficial effects on postoperative outcomes. A restricted perioperative IV fluid regimen aiming at unchanged body weight resulted in reduced complications after elective colorectal resection (1). In another study, patients receiving a reduced intraoperative fluid volume demonstrated less postoperative complications, lower morbidity rates and shorter hospital stay after intraabdominal surgery (2). Conversely, whereas restricted postoperative IV salt and water intake shortened gastrointestinal (GI) function and hospitalization after colonic resection in one study (3), it had no effect on the same outcomes in another randomized clinical trial (4).
Despite the reported benefits of restrictive fluid therapy, this strategy may be associated with adverse outcomes. Inadequate fluid administration can lead to a reduced effective circulating volume resulting in inefficient tissue perfusion (5-7). On the other hand, overhydration, resulting from perioperative fluid excess, has shown association with deleterious effects on cardiac and pulmonary function (8-12), and on recovery of GI motility (2,3,13), tissue oxygenation (14), wound healing and coagulation (15-16). Erroneous fluid administration is generally associated with increased morbidity and postoperative complications (17-21). Altogether, these observations call for a standardized and regulated fluid therapy throughout the perioperative period taking into account patients' premorbid diseases and type of surgery.
Previous studies have focused primarily on intra-operative fluid management. Postoperative strategies have been less well defined, even though the immediate postoperative period is of critical importance to the patient's recovery. Moreover, whereas intra-operative fluid administration is monitored by the anesthesiologist, postoperatively it is less supervised and may result in excess or lack of IV fluids.
The aim of this study is thus to follow and present the current practice of fluid administration in the PACU of Tel Aviv Sourasky Medical Center, for an extended period of time as a first step towards establishing evidence-based guidelines for postoperative fluid management.
Methods
We will collect data regarding intra- and postoperative fluid administration from the charts of >18 years old ASA I-III patients undergoing elective general or orthopedic surgery. Patients with renal/cardiac failure will be analyzed separately, since their pathology dictates extra caution with fluid therapy. Patients demographics, type of surgery, and the type and volume of fluids given during the operation and PACU stay, will be documented as well as the occurrence of morbidity in PACU, without any interventions. Data collection will be anonymous and will last six months. The setting will be the PACU of the Tal Aviv Sourasky Medical center.
Suggested benefits
The purpose of this data report is to provide an overview on the current practice of fluid management in Tel Aviv Sourasky Medical Center's PACU. We believe that this is a preliminary necessary step towards establishing guidelines for postoperative fluid management.
Study Objective
To describe the contemporary practice of postoperative fluid management in the PACU of the Sourasky Medical Center.
References
- Brandstrup B, Tonnesen H, Pott F et al (2003). Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg 238:641-8.
- Nisanevich V, Felsenstein I, Matot I, et al (2005). Effect of intraoperative fluid management on outcome after intraabdominal surgery.Anesthesiology.103:25-32.
- Lobo DN, Bostock KA, Allison SP, et al (2002). Effect of salt and water balance on recovery of gastrointestinal function after elective colonic resection: a randomised controlled trial. Lancet 359:1812-8.
- MacKay G, Fearon K, O'Dwyer PJ et al (2006). Randomized clinical trial of the effect of postoperative intravenous fluid restriction on recovery after elective colorectal surgery. Br J Surg 93:1469-74.
- Arkilic CF, Taguchi A, Sharma N, et al (2003). Supplemental perioperative fluid administration increases tissue oxygen pressure. Surgery 133:49-55.
- Bennett-Guerrero E, Welsby I, Dunn TJ, et al (1999). The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg 89:514-9.
- Mythen MG, Webb AR (1995). Perioperative plasma volume expansion reduces the incidence of gut mucosal hypoperfusion during cardiac surgery. Arch Surg 130:423-9.
- Arieff AI (1999). Fatal postoperative pulmonary edema: pathogenesis and literature review. Chest 115: 1371-77.
- Turnage WS, Lunn JJ (1993). Postpneumonectomy pulmonary edema. A retrospective analysis of associated variables. Chest. 103:1646-50.
- Mathru M, Blakeman BP (1993). Don't drown the "down lung". Chest 103:1644-5.
- Jordan S, Mitchell JA, Quinlan GJ, Goldstraw P, Evans TW. The pathogenesis of lung injury following pulmonary resection. Eur Respir J 2000; 15: 790-9
- Patel RL, Townsend ER, Fountain SW (1992). Elective pneumonectomy: factors associated with morbidity and operative mortality. Ann Thorac Surg 54: 84-8
- Prien T, Backhaus N, Pelster F, Pircher W, Bunte H, Lawin P (1990). Effect of intraoperative fluid administration and colloid osmotic pressure on the formation of intestinal edema during gastrointestinal surgery. J Clin Anesth 2: 317-23
- Heughan C, Ninikoski J, Hunt TK (1972). Effect of excessive infusion of saline solution on tissue oxygen transport. Surg Gynecol Obstet 135: 257-60
- Janvrin SB, Davies G, Greenhalgh RM (1980). Postoperative deep vein thrombosis caused by intravenous fluids during surgery. Br J Surg. 67:690-3
- Hartmann M, Jönsson K, Zederfeldt B (1992). Effect of tissue perfusion and oxygenation on accumulation of collagen in healing wounds. Randomized study in patients after major abdominal operations. Eur J Surg 158:521-6.
- Mutoh T, Lamm WJ, Embree LJ, Hildebrandt J, Albert RK (1992). Volume infusion produces abdominal distension, lung compression, and chest wall stiffening in pigs. J Appl Physiol 72: 575-82
- Ratner LE, Smith GW (1993). Intraoperative fluid management. Surg Clin North Am 73: 229-41
- Moore FD, Shires G (1967). Moderation. Ann Surg 166:300-1.
- Alsous F, Khamiees M, Manthous CA, et al (2000). Negative fluid balance predicts survival in patients with septic shock: a retrospective pilot study. Chest 117: 1749-54.
- Callum KG, Gray AJG, Hoile RW, et al (1999) Extremes of age: the 1999 report of the national confidential enquiry into perioperative deaths. London: National Confidential Enquiry into Perioperative Deaths.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients from both sexes >18 y/o, undergoing elective general or orthopedic surgery
Key inclusion criteria (3 listed)
- Men and women > 18 years old
- ASA I-III
- Undergoing elective general or orthopedic surgery
Key exclusion criteria (1 listed)
- Emergency procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Idit Matot, MD study chair
Department of Anesthesia and intensive care, Tel Aviv Sourasky Medical Center
Yifat Klein, PhD principal investigator
Department of Anesthesia and intensive care, Tel Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Edema and Acute Lung Injury, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2009.