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Fluid Therapy clinical trials

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NCT ID: NCT06351475 Not yet recruiting - Clinical trials for Postoperative Complications

Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy

ALBUCHIP
Start date: September 2024
Phase: N/A
Study type: Interventional

Introduction Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is considered as the standard of care for the treatment of peritoneal metastases. Cytoreductive surgery with HIPEC is characterized by large intra operative fluid shift secondary to surgical resection, peritoneal inflammation and capillary shifts, requesting high volume of intra operative fluid therapy. Previous studies found a strong association between intra operative hypovolemia or volume overload with post operative outcomes. Albumin as an intravenous fluid has been widely studied in critical ill patients, but evaluation of its efficacy during major surgery on post operative clinical outcomes are lacking. We hypothesize that a reduction of intra operative crystalloid volume infusion by using 20% albumin during CRS with HIPEC could improve patients' prognosis. The aim of this study will be to assess the efficacy of 20% albumin combined with Ringer Lactate versus Ringer Lactate for fluid therapy during CRS with HIPEC on post operative outcome at 28 day. Methods and analysis The study protocol has been designed and written in accordance with the Prospective randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial. Recruitment, randomisation and allocation Information on the study and screening of patients will be conducted during the consultation of anaesthesia (= selection visit), 2 months at 3 days before the surgery. Information notice and consent form will be delivered. The day before the surgery, anaesthesiologist who will conduct the pre anaesthetic visit will be able to include patients in the study (=inclusion visit). Randomisation will be done at the inclusion visit after information and signature of consent form of voluntary patients. A randomization number will be assigned. The 1:1 randomisation will be centralized via an online interface ensuring secret group assignment, and based on predefined randomisation lists with variable-size permutation blocks, stratified by center. Randomisation will be accomplished using a computer-generated random sequence. Randomized Open, Blinded endpoint (PROBE) design. This study is a randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial. Intervention - 20% Albumin + Ringer Lactate group (intervention group) Per-operative fluid therapy consisting in Ringer Lactate combined with 20% albumin. Patients will receive a bolus of 3 mL/kg on one hour of 20% albumin from anaesthetic induction. Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery. - Control group Ringer Lactate for intra operative fluid management based on the latest scientific recommendations. As the the study is an open labelled randomized clinical trial, placebo use is not planned. Outcome measures The primary outcome will be the Comprehensive Complication Index (CCI score) at day 28 after CRS with HIPEC. Secondary outcomes are mortality at day 28, CCI score at day 7, volume of intra operative and post operative (48h) post operative fluid therapy, cumulated incidence of surgical post operative complications, cumulated incidence of medical post operative complications, need for mechanical ventilation, renal replacement therapy between surgery and day 28, SOFA score variation between pre operative period and 48h after surgery, number of days alive out of intensive care unit and out of hospital until day 28 Sample size calculation To ensure a power of 80%, a number of patients 130 (65 patients by group) will be necessary with a reduction of 13.6 (SD 24) points of the CCI score at day 28 in the intervention group. Because of a risk of neoplastic evolution between anaesthetic consultation and randomisation (10% of early cancellation), a total of 146 patients (73 by group) will be included in the study. Discussion In summary, ALBUCHIP study will be the first randomized clinical trial assessing efficacy of intraoperative use of 20% albumin combined with Ringer Lactate versus Ringer Lactate during CRS with HIPEC. Results yielded from this study will be helpful for vascular filling during CRS with HIPEC but, thanks to ancillary studies, to improve pathophysiological understanding of this surgery.

NCT ID: NCT06258616 Recruiting - Fluid Overload Clinical Trials

Fluid Administration and Fluid Overload in the Intensive Care Unit

FLUID-ICU
Start date: April 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this international inception cohort study is to describe fluid administration during admittance to the intensive care unit (ICU), and provide contemporary epidemiological data on fluid overload, risk factors, management and outcome in critically ill adult patients.

NCT ID: NCT06256120 Not yet recruiting - Acute Kidney Injury Clinical Trials

Effect of Fluid Regimen on Acute Kidney Injury

Start date: March 20, 2024
Phase: N/A
Study type: Interventional

Postoperative acute kidney injury (AKI) is an important surgical complication that increases hospital stay and mortality when it occurs after kidney surgery. Studies investigating the effects of restrictive or liberal fluid regimen on postoperative AKI during radical/partial nephrectomy have given controversial results. It is important to recognize AKI early so that supportive treatments can be started early. Serum creatinine level, which is frequently used in the detection of AKI, increases late and causes a delay in diagnosis. It has been reported that cystatin C level increases earlier than creatinine in the diagnosis of AKI, so it can be used for early diagnosis.

NCT ID: NCT06249568 Recruiting - Fluid Therapy Clinical Trials

Evaluation of Fluid Responsiveness With Recruitment Maneuver After Sternotomy in Coronary Artery Bypass Surgery

fluidresponse
Start date: June 1, 2023
Phase:
Study type: Observational [Patient Registry]

Assuming that the basic reliability of dynamic indices will increase with the application of functional hemodynamic tests after sternotomy and protective lung ventilation in patients undergoing elective coronary artery bypass surgery, it is useful to predict fluid responsiveness after sternotomy in coronary artery bypass surgery patients ventilated with 6 ml/kg PBW (ideal body weight). We aimed to reveal the sensitivity and specificity of PPV and SVV changes by applying a lung opening maneuver.

NCT ID: NCT06206434 Recruiting - Fluid Therapy Clinical Trials

Point of Care Ultrasound and Co-loading in Patients With Spinal-induced Hypotension and Cardiac Diseases

Start date: January 2, 2024
Phase:
Study type: Observational

In elderly patients with cardiac diseases, changes in cardiovascular physiology diminish cardiovascular reserve and predispose to significant hemodynamic instability after spinal anesthesia; hence, such patients could be at risk of postoperative complications. Additionally, point of care ultrasound (POCUS) and transthoracic echocardiography (TTE) are used in clinical practice to evaluate cardiovascular hemodynamics. Inferior vena cava (IVC) and its collapsibility index (CI) have been used in clinical practice for the prediction of post-spinal hypotension. Specifically, the dIVCmax-to-IVCCI ratio < 48 showed high diagnostic performance among other indices in the prediction of post spinal hypotension in elderly patients with cardiac diseases undergoing proximal fracture repair. According to the above findings, the investigators hypothesized that fluid co-loading immediately after spinal anesthesia can lower the incidence of spinal-induced hypotension in patients with dIVCmax-to-IVCCI ratio < 48. For this reason, it is prospectively evaluated echocardiographic indices of the LV and the right ventricle (RV), as well as of the IVC prior to spinal anesthesia in elderly patients with proximal femur fractures who had low LV-EF.

NCT ID: NCT05968066 Not yet recruiting - Critical Illness Clinical Trials

Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients

PRoFLUID
Start date: December 2023
Phase:
Study type: Observational

The goal of this woldwide observational study is to investigate various aspects of fluid and vasopressor therapy in critically ill invasively ventilated patients. The main questions it aims to answer are: - What is the global current practice of fluid and vasopressor therapy? - What are associations between this practice and clinical outcomes? Participating intensive care units will gather detailed information about fluid and vasopressor therapy prescribed to participants. Participating intensive care units will also gather information about participant outcomes such as duration of invasive ventilation, length of stay and mortality

NCT ID: NCT05961137 Completed - Sepsis Clinical Trials

Orange Park Out-of-Hospital Quality Improvement Study for Improving CMS Sepsis Core Measures

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The goal of this quality improvement study is to measure the impact of incorporation of a manual rapid fluid infuser (RFI) for intravenous crystalloid infusion in patients with suspected sepsis in the prehospital interval. The main question[s] it aims to answer are: - Does the intervention affect the timeliness of fluid administration? - Does the intervention affect CMS sepsis bundle care measure compliance? - Does the intervention affect processes and outcomes of care? - Are there any adverse effects? Researchers will compare this intervention to use of more conventional gravity or pressure-infusion bag crystalloid infusion.

NCT ID: NCT05606536 Recruiting - Microcirculation Clinical Trials

The Impact of Intra-operative Fluid Infusion Rate on Microcirculation

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Intraoperative fluid therapy (IFT) is an integral part of anesthesia care during surgery. Its main indication is the optimization of oxygen supply to the tissues. For elective surgery that is not associated with higher blood loss and a long period of preoperative fasting, including fluids IFT is dosed to cover the basal daily need for fluids. However, it is not clear whether this fluid dose is optimal. Surgery is a stress factor that leads, among other things, to damage of the endothelial glycocalyx (EG). EG binds a significant amount of plasma, which is released during EG destruction and causes relative hemodilution. Isovolumic hemodilution is an established intraoperative procedure that serves to better control bleeding in procedures where bleeding is expected. However, partial hemodilution occurs even with standard IFT, and even when fluids are hardly given at all. Flow parameters in microcirculation have not yet been described depending on IFT conduction. The parameters of the microcirculation reflect its functioning, which will consequently affect the postoperative phase of the patient's moaning and clinical outcome.

NCT ID: NCT05487222 Completed - Fluid Therapy Clinical Trials

Goal Directed and Liberal Fluid Therapy

Start date: January 10, 2020
Phase:
Study type: Observational

The aim is to compare intraoperative goal directed fluid therapy (GDFT) versus liberal fluid therapy in patients undergoing elective colorectal surgery by using noninvasive electrical cardiometry. This study hypothesized that GDFT is better than liberal fluid therapy to provide sufficient intra-vascular fluid volume for adequate perfusion without impairing glycolcalyx function with fluid overload

NCT ID: NCT05369559 Recruiting - Fluid Therapy Clinical Trials

Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department

MIBORED
Start date: March 3, 2022
Phase: Early Phase 1
Study type: Interventional

Intravascular volume expansion is a common intervention in critically ill patients with acute circulatory failure.we test the hypothesis that a mini-bolus fluid challenge, of either 50 ml or 100 ml, can predict fluid responsiveness in spontaneously breathing patients with hemodynamic instability.